Fiona Nash (NSW, National Party) Share this | Hansard source

I rise today to speak in continuation on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. In 1996, this parliament allowed an amendment to the Therapeutic Goods Act 1989. That amendment made the minister for health ultimately responsible for decisions in relation to the importation, trial, registration and listing of RU486 and other abortifacients rather than the Therapeutic Goods Administration, the statutory body usually responsible for the approval of medicines in Australia. This was on the grounds that these drugs amounted to a special category of drug requiring an additional layer of public scrutiny. That debate occurred some 10 years ago, over concerns about the safety of the drug in the context of what was known about RU486 at that time. In 2006, we are 10 years on and there is much more data available. RU486 is now approved in 35 countries, including the United States, New Zealand, France, Israel, Sweden, Russia, Turkey, Tunisia and Britain, but not Australia.

As a senator for the people of New South Wales, my role is to strive to ensure that policies are in place for the benefit of the people I represent. My role is to ensure that I remain open-minded, prepared to consider all views and ideas, in order to provide the best possible outcomes for those people. It is often not an easy task to pursue an idea that may be perceived to be difficult. Yet, when there is a sense of purpose, when you know that encouraging debate on an issue of importance is the right thing to do, it is a path that you follow.

I draw to the attention of the Senate the fact that this bill has been co-sponsored by a Liberal senator, a Democrat senator, a Labor Party senator and me, a member of The Nationals. This is not about party policies. This is about four senators in this place as individuals, with enormous support, who believe, regardless of belonging to different parties, that passing this bill is the right thing to do. I am advised that this is the first time in the history of this place that four members of different parties have co-sponsored a private senator’s bill. I think it brings great strength to the bill that, regardless of our individual philosophies and ideologies, we are united in our belief that passing this bill will be of benefit to people in this country.

I want to very clearly outline what this bill is about. There has been much emotive debate surrounding the issue of RU486. It is important that people have a very clear understanding of the intent of this private senator’s bill regarding RU486 being debated here in the Senate this week. This private senator’s bill was introduced as a result of growing concern that the approval process for drugs such as RU486 was inadequate and that there was a need for a debate regarding that process.

This bill is not about abortion. While the issue of abortion is very difficult and very sensitive—and I respect people’s right to hold the views they do regarding that issue—this bill is not about abortion. Let me explain. We live in a society in which termination is lawful. While we would all like to see as few abortions as possible and we would all like to see much greater education and prevention of unwanted and unplanned pregnancies, we have to deal with the fact that terminations do occur. We also have to acknowledge the fact that, in this nation, we have already had the moral debate about abortion, and the outcome was that termination is lawful. It is lawful under state and territory laws across this land and has been so since the 1970s.

This debate is not about being pro choice or pro life. Those who argue on that basis have misunderstood the intent of this bill. This bill is about whether a method of termination should be allowed to be assessed by the Therapeutic Goods Administration to determine if it is suitable for use in Australia. In spite of those who try to make it more complex, it is as simple as that. This bill is about whether the health minister of the day or the Therapeutic Goods Administration should be responsible for deciding the quality, safety and efficacy of this drug and other abortifacients.

There has been some argument that the responsibility should remain with the minister as there is a necessity for parliamentary scrutiny of this drug because it is related to abortion. Can I point out that it is not parliamentary scrutiny; it is the scrutiny of one minister—the health minister of the day. The minister does not have to inform the parliament if he or she rejects an application for approval of a restricted drug, and, if a drug is approved, the only requirement of the minister is that he or she informs the parliament within five sitting days.

The argument has been put during this debate that the use of restricted drugs such as RU486 is a social policy issue and therefore needs the approval of the minister. I would argue that the social policy issue was determined with the changes to the laws in our states and territories that allowed for lawful termination. This is not a social policy issue. This country has had that debate. This is about determining whether or not a particular method of termination is suitable for use in this nation.

The question is: who is best able to assess this drug? In what has become a very emotive debate, the heart of the debate—indeed, the crux of this bill—is who is best able to assess it. I would put to honourable senators and to the people of Australia that it is the Therapeutic Goods Administration. There is no one person in this parliament who is qualified to make clinical and/or therapeutic judgments on this drug. If we take the premise that the debate about abortion has been had and the result was lawful termination then we should be allowed to assess methods for that termination.

I am not going to stand here today and argue as to the safety of this drug. There is a deluge of information on the safety or otherwise of RU486. Depending on what you read, you could be equally convinced that it is either completely safe or completely unsafe. Reading information from the internet does not give us the ability as legislators to determine the safety of this drug—or, indeed, of any drug. I can assure you that I do not have the qualifications or ability to assess the quality, safety and efficacy of this drug. And that is exactly the point of this bill. As I said earlier, I do not believe that any of my colleagues in this place—or indeed in the other place—have the ability to do this either. And I do not believe that any of my colleagues in either place could, in all honesty, disagree with me on that. The ability to assess the quality, safety and efficacy of this drug rests with the Therapeutic Goods Administration.

I have listened very carefully to all sides in this debate. I have read carefully and studied the views of the community. I have listened to those who attended the Senate committee inquiry, and I respect the views of all of those people. However, one of the views of those that are against the bill is that they do not believe that RU486 is safe. There is much varied literature regarding this drug but, as I said before, there is much information supportive of both sides in this debate. As Benjamin Disraeli said, there are three kinds of lies: lies, damned lies and statistics.

Those who are against the use of RU486 because they are concerned about the safety aspects of these types of drugs should not be concerned about supporting this bill. This bill does not say that RU486 should be used in this country. This bill does say that the Therapeutic Goods Administration should be allowed to assess the drugs in this category. Those people who have concerns about safety should welcome the assessment by the TGA if they are so sure that this drug is unsafe. If their concerns about safety are correct then the TGA would not approve the drug for use in Australia.

There have been concerns put forward that RU486 would lead to an increased incidence of abortion. These concerns are unfounded and could not be substantiated by any submission or witness to the recent Senate committee inquiry into this bill. There have also been concerns put forward about the ability to safely administer the drug in rural areas, saying that the circumstances were not appropriate for use in those areas. Quite frankly, I think this is an appalling slight on our rural medical practitioners. If a situation was not suitable for a woman to use RU486, quite simply the practitioner would not prescribe it.

The Therapeutic Goods Administration is trusted by this government to ensure that medicines and medical devices used in this country are of a very high standard and at least equal to, if not better than, that in comparable countries. We have a TGA that is highly regarded the world over. The government turns to the TGA to ensure that the delivery of medicines and medical devices in this country is of the highest possible standard. According to the Therapeutic Goods Administration’s 2004-05 annual report, 49,343 items were listed on the Australian Register of Therapeutic Goods.

Can I just say on that that there has been some argument about RU486 not being therapeutic as it does not treat a disease. I would argue that the Therapeutic Goods Administration assesses many drugs that are not for a disease—for example, the oral contraceptive pill—and it also assesses medical devices such as prosthetic joints, intra-uterine devices, medical gloves, syringes, condoms and disinfectants. Many of those who oppose this bill are letting the words used in the name of the body most able to assess this drug cloud the fact that the Therapeutic Goods Administration is indeed the body most able.

We trust the Therapeutic Goods Administration to evaluate and monitor around 50,000 items for the people of this nation, often dangerous drugs, and we believe they will do it safely and effectively. Yet the opponents of this bill are saying that the TGA does not have the ability to determine the quality, safety and efficacy of eight particular drugs because those eight drugs fall into a restricted category. That is eight drugs out of almost 50,000 items that we entrust the TGA to put on the Australian Register of Therapeutic Goods. Those drugs are alprostadil, carboprost, dinoprost, dinoprostone, gemeprost, mifepristone, misoprostol, prostaglandins and vaccines against human chorionic gonadotrophin. We are saying at the moment that the TGA has the ability to assess and approve 49,343 drugs, items and devices—but not those eight.

There are those that say the TGA does not have the ability to make a moral evaluation of the social issues surrounding the drug RU486 and others like it. The Therapeutic Goods Administration does not need to have that ability. The moral evaluation of the social issues has already been done in the debate in this nation that led to termination being lawful. How can we say that, in a society where termination is lawful, we will allow surgical termination and yet we will not allow medical termination to even be assessed? It is illogical.

There have been, and will be, many speakers on this bill. There will be many different points of view; there will be many different arguments. There will be emotive arguments. What I ask is that we look at this bill for exactly what it is: a bill that would allow a method of termination to be assessed by the Therapeutic Goods Administration, the only body properly qualified to do so in a society where we have agreed that termination is lawful. I urge senators to support the bill.