Kerry Nettle (NSW, Australian Greens) Share this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is about who is best placed to assess the safety of the drug RU486, about who can determine whether this drug is safe for use in Australia. The Greens and the majority of people in our community believe that the body that has been set up by the government to assess the safety of drugs—that is, the Therapeutic Goods Administration—is best equipped to make this decision about whether this drug is safe for use in Australia. The Greens believe that the Therapeutic Goods Administration has the appropriate experts and is in the best position to decide whether the drug is safe because it was set up for that specific purpose. It is trusted by the whole of the Australian community with the responsibility to determine whether every other drug is safe for use in Australia. The Greens say that that should also be the case in relation to this drug.

It is worth asking the question: what is the point of the government setting up an organisation like the Therapeutic Goods Administration specifically for that purpose, if we want to stop it from doing its job? What is the point, if we want a Minister for Health and Ageing who is able to say to a body he sets up and appoints to carry out this important responsibility, ‘You can’t do your job’? The Greens say: let the Therapeutic Goods Administration get on with doing its job of making decisions about whether the drug is safe for Australian women.

There are others in the community who hold the view that, somehow or other, the minister for health is best placed to decide whether or not this drug is safe. With all respect to current, former and future health ministers, the Greens do not share the view that one individual is better placed in making this decision than the body set up to do this for the whole country. Health ministers are just individuals and do not necessarily have any medical training. They can seek advice from anywhere they choose; they can base their decision on information from anywhere they like. They do not have to base it on medical evidence. They can base it, if they choose, on their own personal views and their ethical, religious or moral perspectives. There is no accountability in the way in which one individual makes any such decision.

It is unfortunate that many people who oppose this view mistakenly believe that having the health minister decide whether this drug is safe or not for use in Australia somehow offers a form of parliamentary scrutiny. This is not correct. A Parliamentary Library research note explains:

Under current arrangements, the Minister is simply required to notify the Parliament of a decision to approve an application for evaluation by the TGA. Given the fact that such a decision would not be disallowable—

by the parliament—

this does not amount to a significant level of parliamentary scrutiny. Further, the Minister is not required to table decisions not to approve such applications, meaning that the Parliament would neither necessarily be informed nor have the capacity for any oversight of such a decision.

And neither does it require the reasoning and the rationale on which the health minister may make such a decision. The better process is to allow the Therapeutic Goods Administration to do its job in the open, transparent and accountable way that government departments are designed to work, and to carry out this very task. This would allow it to gather together the experts and have a fully accountable, independent, transparent and scientific evaluation of this drug. This method of decision making about the safety of this drug is good governance, and this is the manner in which the Therapeutic Goods Administration was set up and designed to operate. It is authorised to evaluate, approve and regulate therapeutic drugs in the public interest.

We all—and governments in particular, having set the body up—know that the Therapeutic Goods Administration operates using robust and thorough risk assessment procedures. That does not mean, of course, that it gets it right 100 per cent of the time. No science is that exact, and no decision-making body like that is that exact. Some people who oppose this bill have pointed to a handful of well-known examples where the Therapeutic Goods Administration has changed its recommendations and advice in relation to particular drugs, and these people have sought to use this to prove that the Therapeutic Goods Administration makes mistakes. But, in fact, these examples do not suggest that the Therapeutic Goods Administration is unreliable. Rather, they show that the Therapeutic Goods Administration is capable—as it should be—of reasonably reacting in the public interest to new information whenever it surfaces. They are evidence of the way in which the Therapeutic Goods Administration has an ongoing role in determining the safety of drugs that are used in the Australian community.

Unlike the decisions of a single unaccountable member of parliament—who, like any individual, may be prone to powerful internal and external influence—the Therapeutic Goods Administration is set up and transparently designed to protect the public from vested interests. When it comes to health care and the pharmaceutical industry, we all acknowledge that there are very powerful interests involved; it does not matter if the pressure comes from profit-chasing pharmaceutical companies or from desperate consumers with chronic and life-threatening illnesses. The Therapeutic Goods Administration has been set up and is relied on in this country to dispassionately protect the public interest through its clear, accountable and transparent standards and via full reporting through the minister to the parliament—unlike that single individual health minister, whomever that may be.

The Greens agree with the submission that came from Sexual Health and Family Planning Australia, which argued that the Therapeutic Goods Administration provides:

... appropriate, objective, apolitical conclusion based on the efficacy, quality and safety of a drug and its suitability for use by Australians.

The Therapeutic Goods Administration is held in high regard by the World Health Organisation. It has the prestigious status of being a World Health Organisation Collaborating Centre. That is not a status that is afforded to all such regulatory bodies in countries around the world. Rather, the TGA, like a number of others, has been singled out for recognition for the work it does.

Unfortunately—and others have mentioned it—during the debate there have been people who have misunderstood what the debate is about and have sought to have a debate about whether or not people should be able to access terminations in this country. Unfortunately for them, we have had that debate. That is not to say that people agreed with it, but it has been settled. It is right for people to express their views, but, unfortunately, this debate we are having now is not around that issue. This is about what is the appropriate body to determine whether a drug is safe or not. As I keep saying, the Greens believe that that is the body we have set up to make such decisions in all cases—the Therapeutic Goods Administration.

As I said, the problem for people pursuing that argument is that, when we have had debates about whether access to termination should be available, we have come to the outcome that nearly every other modern Westernised nation has reached. The World Health Organisation describes terminations, either surgical or medical, as one of the safest medical procedures that people are able to access. In July last year it placed RU486 on its list of essential medicines. There is an inherent weakness in the argument being put forward by opponents of this bill that this drug is unsafe and therefore it should be rejected. If that were the case then one would imagine that people who are concerned about such issues would want to see its safety and efficacy evaluated by the Therapeutic Goods Administration. If there is genuine dispute over the safety of the drug then it is the Therapeutic Goods Administration that is best placed to cut through any disputed evidence.

Unfortunately—and, again, others have mentioned this—as we often see in intensely political debates, statistics are used in a whole variety of different ways. Indeed, the same statistics are used to substantiate very different arguments. There has been inaccurate reporting of statistics. For example, a number of people who oppose not only this bill but also all access to terminations will talk about the figures for people within the community who are concerned as a way of substantiating their argument. Unfortunately, when you then look at the actual questions that were asked and the answers that were provided, what you find is that even those organisations which are seeking to get a different result find again and again that the majority of Australians support the right of women to access terminations in this country.

A lot of the studies that have been done by people opposing this bill unfortunately have not followed the sorts of rigorous processes that we expect of organisations that are doing such studies. There have not been independent polls carried out. They have not been willing to release the questions that they have put forward. One example is a survey that is available on the Australian Federation of Right to Life Associations website. We heard about this today from Professor Terence Hull, a professor of demography at the ANU. He said he would be giving it to his students as an example of the way in which a survey should not be done. It involved ringing up 12,000 people in order to get the 1,200 answers that were used.

Professor Hull today went through the reasons why he would be using this as an example of the way not to carry out surveys. He quoted from their website the preface that was put when people were asked these questions. Prior to being asked questions about their attitudes about this issue, people were read a preface which came from a particular perspective. When we talk about push polling, this is what we are talking about—people being given a particular view and then being asked if they agree with that. It is really sad to see people choosing that method as the way to try to substantiate their views. It is perhaps not surprising when time and time again for decades people in the Australian community have been asked what their view is and the majority of Australians have said that they think women should be able to choose.

A related argument that was pursued by opponents of this drug concerned the claim that the availability of drug RU486 would increase the number of terminations carried out in Australia. But, when pressed about this issue in the Senate inquiry in Melbourne on Friday, certainly one of the doctors who was claiming there would be an increased number of terminations if RU486 was available had to admit that there was no evidence of that. He had to say to me that from nowhere in the world could he provide evidence of where that had been the case. The only evidence like that he had seen related to other drugs but not to RU486. It is unfortunate to have that kind of argument being put forward and not being able to be substantiated. The committee in fact heard evidence that, where RU486 had been available—in places like Sweden—it actually reduced the overall number of terminations that were carried out.

Of course, it is always worth noting that one of the features of this particular drug is that it can be used early in a pregnancy. When we put as a primary concern the issue of women’s health, to be able to carry out a termination earlier rather than later in the pregnancy brings great benefits for the health of the woman involved. That is what this drug enables people to do. Also, women who make the difficult decision to proceed with a termination are able to proceed with that termination at the time that they make that difficult decision rather than wait around for a long time and experience stress and angst because they cannot access the medical procedure that they at that time are requiring to access.

Again, unfortunately there has been some misinformation in relation to RU486 being used in rural and remote settings—and that led to the Chief Medical Officer needing to comment through his spokesperson that the Minister for Health and Ageing had misinterpreted the information that had been provided to him. That is an example for us of the difficulties that occur when a minister for health is put in that position. It is not their fault. They are appointed to that position with no medical training and they have to interpret advice that they seek and they can misinterpret it, which is what happened in this instance. That is all the more reason that that decision should be made by the medical experts, who are used to assessing the safety and efficacy of drugs, rather than by an individual who happens to have been placed in that portfolio and may or may not have any understanding of the issue.

To conclude, the Greens are proudly a pro-choice party—but that is not the issue we are talking about here. The issue we are talking about here is: who should make a decision about the safety and availability of this drug in the community? The Greens say that that is the body set up to do this very job: the Therapeutic Goods Administration. We are pleased to have the opportunity to be able to be supporting this private member’s bill. We want to see the body tasked with this job, the Therapeutic Goods Administration, looking at the evidence—looking at the 35 other countries where this drug is available and looking at the circumstances of the millions of women who have been using this drug for many decades in other countries—and, on the basis of that evidence, making a decision on whether or not this drug should be available in the community. I certainly want the medical experts deciding issues that relate to women’s health in this country, rather than the man or woman who happens to have been assigned to a particular portfolio and who may have no medical training in this area. I want to see the experts do their job. That is the opportunity we have with supporting this bill before the Senate.

I seek leave to table another part of the petition that Senator Moore just tabled, in which people are expressing their views in relation to this particular bill.

Leave granted.

Thank you. I commend this private member’s bill to the Senate.