Mr Tony Burke (Watson, Australian Labor Party, Shadow Minister for Immigration) Share this | Link to this | Hansard source

I suspect this is a speech which will make few people happy. Those who will be voting against will be disappointed with the conclusions I have reached, and those who are happy with the way I intend to vote will no doubt be disappointed with my reasons. I want to talk about the debate and discussions which have surrounded the lead-up to this bill—the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005I want to talk about what this bill is not about and, finally, I want to talk about the legislation that is before us.

This is the fourth time I have been asked to exercise a conscience vote in a parliamentary debate. The previous three were in the New South Wales parliament. In a conscience vote, I believe deciding how to vote should be made entirely on the basis of the bill which is before us and the consequences it will have if made law. I had hoped to commence this speech in the same way I have opened other speeches on conscience vote issues, by noting and being grateful for the decency with which other members of parliament had conducted themselves in this debate. But I cannot. Too many people have been maligned by antireligious comments—some have been specifically anti-Catholic, some more generally anti-Christian and some more recently anti-Muslim. At least Senator Nettle bothered to apologise for any offence she caused to Catholics and high Anglicans.

I do believe we live in the best country in the world and, for all the differences around this country, we have to wake up every morning and still live together, still get along and still make a great society work. Every day we see people on all sides of the parliament show leadership in trying to keep everything cohesive. I say to both the member for Hughes and Senator Nettle that they have hurt people deeply and made problems worse. At the end of this debate I will be voting the same way as the member for Hughes, but at least it will be for very different reasons. My reasons are about the bill.

I do not believe we are being asked in this vote to approve the use of RU486. Even if this bill is defeated—which appears highly unlikely—health ministers change. I believe RU486 will probably be approved by a health minister in the next few years, even under the current rules. If the last cabinet reshuffle had been more extensive, there may well have been a minister already willing to approve it. The fact that the previous health minister voted in the Senate in favour of this bill only reinforces this point.

Most of the correspondence I have received deals with the merits or otherwise of RU486. I find it hard to base my decision on this bill on those arguments when I honestly believe the drug is going to come into use whether or not this bill is passed. I do not believe we are being asked to adjudicate the abortion debate, which will always be addressed by state laws. I do not believe we are being asked to vote on a motion of no confidence in the Minister for Health and Ageing. I do not believe we are being asked to choose between the health minister and the Therapeutic Goods Administration. The bill asks us to choose between a process where both the health minister and the TGA have a role and a proposal where the TGA would act alone.

When most drugs are going through an approval process there is no community debate which accompanies their consideration. RU486 is one of the rare occasions where such a debate exists. In the years to come there will be a number of drugs on which there will certainly be community debate. The member for Bowman touched on some of these. I suspect the attitudes of members of parliament on some of these drugs will be wildly different to the way they are lining up this week.

We have a fairly simple choice: either we have a process that takes into account that community debate or we do not. It is not an unreasonable position to say that the only issues to be considered are the scientific ones. If that is the conclusion you reach, then you would keep members of parliament a long way away from the deliberations; you would leave it to the expert bodies alone. I reach a different conclusion. I believe we are better off with a mechanism that considers community debate. That consideration should be performed by people who are accountable or, at least with this government, answerable to the public. The mechanisms by which you do that will always be imperfect. I know only too well from my own portfolio area that the existence of ministerial discretion does not mean it will be used all that well, but I do not find myself arguing that therefore ministerial discretion should go.

There are two amendments under discussion which would allow a different process, which would end in parliament voting on a disallowable instrument. There are limits to the merit of turning the debate back to us, but the alternative to those mechanisms is that we are left with a policy decision that says the community debate will be ignored; that the scientific argument will be all that is heard. I am not convinced about the relative merits of the various amendments which are under discussion, and I am concerned about one of them being a second reading amendment. I will be following the debate closely, but at this stage the amendment in the name of the member for Bowman seems to make the most sense to me. It has the added benefit of focusing the debate on the principle of any drug where there is significant community debate rather than simply focusing on RU486.

Most drugs will be non-controversial, and the main arguments will relate to the expense of placing them on the PBS. Increasingly, though, there will be significant community dissent over issues that have nothing to do with the scientific merits of a drug. It is certainly not the TGA’s job to consider that community discussion, but I do believe it is ours. That is why I intend to oppose the private member’s bill before us.

I am not naive about this. I know that most people will not read this speech and will simply presume from a voting list what my reasons were. Some of those who do hear or read this speech will think that I have not disclosed my real reasons and will revert to the curious concept that anyone with religious faith loses their intellect in the process. I can only call it as I see it. I do not believe I am voting about whether to allow RU486, because I believe it will probably become available under any of the four systems under discussion.

While my faith does form part of my own philosophical approach, I find it to be distinctly unhelpful in this case. I believe we are voting on the process, and I have never heard of the parable of the minister and the expert panel. I am conscious as a member of Labor’s frontbench that these views are very much my personal views. The party’s position has been articulated by the shadow minister for health, and we have the freedom to vote however we want. I have refrained from commenting on this issue outside of the parliament, and that will not change.

We have a piece of legislation before us which I believe, unless it is heavily amended, will make the current, imperfect system worse. In a conscience vote you have to call it as you see it. I cannot support this bill.

Andrew Robb (Goldstein, Liberal Party, Parliamentary Secretary to the Minister for Immigration and Multicultural Affairs) Share this | Link to this | Hansard source

I rise today to speak against the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I did not come to this place to be a moral crusader, but on issues such as this I will seek to stay true to my convictions. As such, I will vote against this legislation. I cannot support any legislation where my vote, as much as the legislation itself, has the potential to encourage more abortions. At a personal level, I believe abortion is one of the most difficult and confronting issues facing society. It is no doubt a deeply personal and traumatic matter for so many women; and while the fate of the foetus is practically and ultimately a decision of the individual woman it can be a deeply personal and traumatic matter for the father of the foetus.

For those like me who believe that human life begins at conception, it only magnifies the moral dilemma and, despite what many in this debate have suggested, it is a moral issue for men and women alike. For that reason I am acutely conscious of any decision I take in this House which might telegraph support for a lessening of the absolute seriousness of the decision to have an abortion. My concern is that a yes vote by the community’s federal parliamentary representatives to delegate responsibility for the availability of the abortion pill to a purely technical process will send a powerful message, especially to young people, that we as a community are becoming more indifferent to, or blase about, abortion. It will further condition Australians to see pregnancy as merely another medical condition, where abortion is seen as elective surgery or an elective drug treatment without at the same time encouraging our fellow Australians to also consider the moral, ethical and social dimensions surrounding such a momentous personal decision as aborting a foetus.

We must not underestimate the impact of the public policy decisions we make in terms of their effect on the moral compass of Australians. Take, for instance, the situation in China. The Chinese government has for many years advocated a one-child policy. This has meant that many couples in China routinely carry out terminations in order to comply with this policy. This has reportedly created a ‘conditioning’ of that community, where terminations are acceptable, almost routine, like the removal of a wisdom tooth.

In the same way, a yes vote for this bill will have the effect of absolving those people who may unfortunately be confronted with this most difficult issue from properly considering also the moral and social aspects of such a decision. A decision by this parliament to delegate responsibility for the use of an abortion drug to a technical committee would further the aim of those in our community who would prefer to medicalise pregnancy as though it were simply another medical condition. Whatever personal decision an individual arrives at, to me it seems seriously wrong and dehumanising to encourage the decision to be seen as principally a medical matter, to downplay or to expunge the spiritual and social dimension of any decision to have an abortion.

As well, the revolution in biotechnology is seeing the development of a range of most extraordinary drugs that will go to market over the next decade. The member for Bowman yesterday identified drugs to do with intellect enhancement and mood elevation, biopharma developments of drugs in plants and food, and other abortion medications, to name a few. The use of any of these drugs will pose highly controversial moral and ethical considerations for our society. I cannot see how the community in the future will accept that the decisions about the availability and use of these future drugs should be left simply to a technical committee which looks only at the safety and efficacy of a particular drug, just as I cannot accept that this current debate is only about the safety and efficacy of RU486. These are all decisions which have much broader ramifications than safety and efficacy. These are decisions we have been elected to take because they are important matters that, in the end, can very materially shape the type of society in which we live. We must not shirk our responsibilities in this regard.

The strategy of those advocating this amendment has been to narrow the debate—to assert that it is not about abortion, to claim that this bill is purely about removing the responsibility of the health minister of the day to decide the quality, safety and efficacy of this drug and to place the decision with the Therapeutic Goods Administration. Yet, in the way this debate has unfolded, it has become political. It has become about abortion. I suspect it always was. Ironically, this is evidenced by the fact that the mountain of correspondence urging me to vote yes invariably includes advice to me that my electorate is undoubtedly pro-choice and that I should vote accordingly. How we vote on this bill will be read in the broader context of the parliament’s general attitude about abortion.

Narrowing the debate to supposedly technical matters is a clever strategy. It is a strategy which allows people to have a foot in both camps. It allows individual members and senators to profess opposition to abortion while voting, wittingly or unwittingly, to further numb the community’s sensibilities to the moral and social issues that should also be in the minds of people when contemplating abortion.

In voting no, I am not trying to impose on others my ultimate views about abortion. Rather, in all good conscience, I cannot be party to a yes vote which will further condition the community to see abortion as merely a medical condition and, in doing so, send a message that encourages more abortions.

Wayne Swan (Lilley, Australian Labor Party, Shadow Treasurer) Share this | Link to this | Hansard source

As a member of this House, I believe my vote on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 should be decided not only by the scientific, safety and procedural considerations around RU486 but also by fundamental ethical principles concerning what is best for the health and wellbeing of the mother and the rights of unborn children. As community decision makers, we cannot ignore the emotional debate surrounding this vote. Australians are people who hold values dear. It is very sad to see Senator Nettle denigrating these values by cheap, T-shirt sloganising. The responsible way to deal with this emotion is to feel confident in ourselves that we have soundly examined all these values and made our decision by considering the arguments on all sides in a measured, mature and ethical way. It is crucially important to have freedom of discussion and respect for other points of view. This is the mark of how a civilised society faces challenges and moves forward.

There are good and well-meaning Australians who argue that life begins on day one of conception. There are other good and well-meaning Australians who adhere to the belief that embryonic cells do not constitute a human life—that is, that they are not yet a child. There are good and well-meaning Australians who anguish over the principle of justice: how do we reconcile the rights of the mother with the rights of the unborn? How do we determine the value of one life over the other? There are also good and well-meaning Australians who believe in covenantal integrity—that is, that conception carries with it an obligation to nurture a potential child. Other good and well-meaning Australians see this as a much more complex issue involving the future quality of life of the mother, the family and the potential child.

While all of these values and principles are faithfully held by the various communities having a voice in this debate, and while all of them should be heard, considered and understood by us in this chamber, in the end our debate is not about a decision to terminate. Our vote is about what options are available to a woman and her medical practitioner after the decision to terminate has been made. It is invasive surgery exacerbating the anguish the woman is already suffering or a medication which, if appropriately prescribed, can potentially, to some degree, lessen the suffering and anguish.

RU486 is a medical treatment option. Among other treatments, it can also constitute a procedure to terminate a pregnancy. But by the time a medical practitioner comes to consider whether it is an appropriate option for treatment in this regard, a decision has already been made, under and within Australian laws, for legal and valid reasons, to terminate the pregnancy. While we cannot ignore the emotional tidal wave that the debate over the use of RU486 has triggered—we would be poor representatives if we did—we cannot forget the crucial point that, by the time the medical practitioner comes to consider procedural options, the decision has already been made. RU486 is the only pharmaceutical drug in Australia that is not regulated by medical and pharmaceutical professionals from the Therapeutic Goods Administration. We rely on these professionals to administer the availability of a range of other medications, some of them potentially harmful or addictive. They carry out this role in an unbiased and knowledgeable way. Personal beliefs do not come into it, nor should they.

And that brings us to the ethical dilemma. When addressing the parliament in 2002 on embryonic stem cell research, I made reference to the conclusions of a committee established by the House of Lords to examine embryonic research. The view of that committee asserted that, in the initial stages of development, embryonic cells do not constitute a human life even though they are alive in the biological sense—that is, that they are not yet a child. I stated in 2002 that I am convinced by the conclusions of this committee. I do, however, believe that the highest respect and most stringent regulation should be applied to interventions during the early stages of embryonic development.

These decisions must be governed by the law of the land, by a medical consultation between a woman and her doctor and by consultation between a woman and her family. As a father of three luckily healthy children, and as a non-Catholic father in a Catholic family, I can only guess at the trauma a woman must suffer when faced with this choice. No-one takes decisions such as this lightly—no-one could—and I regret some of the more outrageous sloganeering and dismissive language that has crept into what is one of the most difficult and sobering debates we could be involved in.

The federal Labor caucus has agreed to a conscience vote on RU486, which I believe is appropriate for an issue such as this. Australians are fortunately people of conscience. We are fortunately people who care for our fellow citizens and we are people of compassion. I will vote in favour of this bill. I will do so having listened to all sides of this argument. I will do so understanding the well-meaning contributions made to it by people on all sides who hold principled values and beliefs. I will do so because I believe it is not appropriate for the personal values and beliefs of a minister for health, of whatever persuasion, to dominate over the scientific, safety and medical considerations inherent in how the use of all other drugs is regulated in this country. As a member of the House, I respect the views of all those who have contacted me on this issue, regardless of whether they align with or are contrary to my own view. That is my custom as an MP and it will continue to be so.

In addressing RU486 and examining its regulation in the context of all these arguments, I am also mindful of the overseas experience with this drug. In the United States, France, the United Kingdom and Canada, RU486 has been available for some 20 years as an alternative to surgical termination. Despite claims to the contrary, it is also available in China. Research and monitoring has found that the drug has not replaced surgery as the most common method of termination. In France it is used in only around 10 per cent of terminations. The availability of the drug has not impacted on the number of terminations in these countries.

There is nothing ‘DIY’ about terminations involving RU486. As in the case of surgical abortions, they require medical oversight and approval. And, contrary to recent claims, it is not a special drug unlike any other: there are a number of pharmaceuticals used in Australia and registered by the TGA that can end human life, and it is not the only medicine capable of causing miscarriage. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has stated that ‘there is a substantial body of literature establishing the safety and efficacy’ of this drug. RU486, like every other pharmaceutical, should be dealt with by independent medical experts at the Therapeutic Goods Administration who can be relied on to make decisions about safety in an unbiased and knowledgeable way. Such decisions should not be made on the basis of the personal beliefs of the minister, whatever their personal opinion may be.

On this occasion my vote is made on the basis of evidence that there is no valid reason why availability of this drug should be regulated differently to any other, that there is no evidence that this drug will significantly impact on the number of legal terminations and that RU486 is one of the options available to a woman and her doctor after a very difficult decision has been taken. This difficult decision will need to be taken under and within Australian laws, regardless of the availability of RU486. If its availability can make the procedure which follows that decision a little easier on the woman involved, why would a caring, compassionate and values driven society like ours not take that path? I support the bill.

Chris Pearce (Aston, Liberal Party, Parliamentary Secretary to the Treasurer) Share this | Link to this | Hansard source

I rise today to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I would like to say from the beginning that I have found this debate to be deeply troubling at a personal level, as the whole issue is a very difficult and complex one. It is an issue that leads me to examine my most fundamental beliefs. And it has been difficult not just for me. The issue has, understandably, generated considerable debate relating to a broad range of issues around this subject.

I want to make a few points that are important to me and which will, I sincerely hope, make a worthwhile contribution to the debate. But, before I do, I would like to say that I do not like abortion. In fact, I find abortion very disturbing and most uncomfortable. I believe that there are far, far too many abortions in Australia and that we—‘we’ being governments at all levels—together with community organisations should work earnestly to support and help people who need assistance and guidance when they find themselves in a situation where the question of an abortion arises. I believe there may be and are particular circumstances or situations where, regrettably, abortion is the only option—an option of last resort. When and if this terrible situation occurs, in the end only the people involved can make the decision that they believe, based on their own beliefs or their own unique circumstances, is best at the end of the day for them.

Another important and absolutely fundamental point I would like to make is that, regardless of who approves what with regard to RU486, if this drug is assessed in Australia to be dangerous and unsafe in any way I do not want anyone or any authority approving RU486 for use by anyone—full stop. If this drug is found to be unsafe, based on the accepted rigorous analysis and evidence based evaluation that exists for all drugs in our country, it should be banned totally.

I also would like to say today that my position should in no way be taken as a reflection on the current Minister for Health and Ageing, Tony Abbott. He has been, is and will continue to be an outstanding health minister serving the people of this nation. Having said that, it requires me, as a matter of responsibility, to turn my mind to what is actually being asked in the bill that is now before the House. I make the point about what is ‘actually being asked in the bill’ because, regrettably, there has been an enormous amount of misinformation disseminated in the community from all quarters about what we are being asked to decide upon in this bill.

On this point I would just like to say how disappointed I have been in the misinformation relating to this important issue. Whilst I can appreciate that both individuals and organisations will seek to influence debates, I have been alarmed at what seems to be almost the deliberate skewing of information to suit one agenda or the other. We as members of parliament are being asked to decide whether it is appropriate that in the case of one drug, and one drug alone, RU486, written approval is required from the Minister for Health and Ageing before this drug can be evaluated, registered, listed or imported into Australia. As a result of what is actually in the bill, I have reached the view that this is an issue not about abortion; I believe it is an issue about what is the best and most appropriate governance process relating to this important discussion.

In considering the issues I have just mentioned there are many, obviously, who are divided on what is the best approach to take to answer the questions I have outlined above. Many people are happy with the status quo because they believe it restricts the drug in our country—that is, they like the idea of the minister of the day having the right of veto. It seems to me, however, that these people—those who support the status quo—might hold a different view if, in their opinion, the minister making the decision was likely to approve the referral of the drug to the TGA. And I suspect the same would apply to those who wish to see the minister’s power of veto removed. Would they be waging a campaign against the ministerial veto if they were confident that the minister making the decision was going to give them the decision they want?

Therefore, as I have said before, I hold the view that what we are actually being asked to decide upon here is very much a governance and procedural issue and should be considered on that basis alone. That is, let us set aside the ideological question and the personal biases from all viewpoints and consider it as a question of governance and appropriate procedure. In reaching my decision, I have thought about this issue for many hours. I have thought about whether my logic is right. I have thought about whether I have approached this issue in the right way—that is, that my logic is sensible and that this is not a matter about abortion but, rather, a matter of governance and process. I hope my thinking proves correct. In the end, one day I will know, but it may not be in this life. It has been very difficult. However, my thinking has led me to a decision to support the bill that would allow the TGA to assess this drug in line with the procedures for all other drugs in our country.

Two of my colleagues have moved or foreshadowed amendments to the bill. I understand that there remains some clarification needed to ensure that these amendments would actually work as they are intended. I believe that the amendment circulated by Mr Laming, the member for Bowman, can potentially allow for an appropriate process that may meet my concerns. As a result, if it will work as it is intended then I would be happy to support this amendment, which would allow the TGA to evaluate this drug but allow their decision to be disallowable by the parliament. However, I want to stress again very strongly that if, after assessment, this drug is deemed to be unsafe then under no circumstances should any person or any authority approve it.

Some people may be aware that I am a member of the Uniting Church in Australia. Furthermore, many people are aware that I very often—and I stress: very often—do not agree with the views as expressed by my church on a whole range of issues. However, I do believe that the president of the church, the Reverend Dr Dean Drayton, does offer some wise counsel on this issue. Dr Drayton said in his media release:

The Uniting Church hopes that those engaged in this debate do not lose sight of the complexity of the issues.

I do think this is wise counsel because it is a complex and profound issue.

As I stand here today and express my views on this issue, I must admit that I remain most uncomfortable and most uncertain about whether my thinking on this matter is appropriate and indeed right. I remain uncomfortable as to whether or not it is right according to what we are called to do for the good of all people. I can only hope that people will accept, while maybe not agreeing with me in total, that I have, with the very best intentions, arrived at my decision sincerely and only after a great deal of soul-searching.

Joel Fitzgibbon (Hunter, Australian Labor Party, Shadow Assistant Treasurer and Revenue) Share this | Link to this | Hansard source

Many earlier contributors have indicated to the House the capacity in which they speak to this very important bill, the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005some as Christians, some as politicians, some as medical practitioners, many as people who have been touched by the issue of abortion in the past and, while not admitting it, some as hypocrites. I approach this debate both as a legislator and a father who understands the importance of choice.

I noted that the member for Watson indicated to the House that this is the fourth occasion on which he has been required to cast a conscience vote. It caused me to think, and it reminded me that this is my third. The first occasion was during the debate on euthanasia. When I voted in support of the bill to overturn the Northern Territory’s right to sanction legally the option of euthanasia, many people thought I did so because of my Catholic faith. While that might have influenced my thinking, they are basically wrong. I did so because I believe in choice. On that occasion my fear was that if we shifted from the current system to a strict sanctioning of the use of euthanasia then people would lose a choice—they would feel pressure, as a burden on family and loved ones, to take the euthanasia option. That is the basis on which I opposed the proposition of the legal sanctioning of euthanasia.

My second experience was on the issue of stem cell research. I supported that proposition, again because I wanted people to have choice—on that occasion, the choice to live and the choice to access modern medical science, the sort of science which provides them with the opportunity to live. On this occasion I am also backing choice: a choice for women and a choice for their health practitioners. That is what this bill is about: the right of women to choose other options. It is not about abortion, a matter which has been determined by popularly elected governments in every state and territory in this country in decisions we should not seek to overturn by using the power we have to regulate pharmaceuticals.

Throughout the course of the 1990 republic debate, the member for Warringah consistently and aggressively argued that you could not trust politicians. ‘I wouldn’t trust politicians to choose my wife. Why should I trust them to choose my president?’ he told one of the many forums he attended advocating the idea of retaining the Queen of England as our head of state. The member for Warringah’s analogy no doubt reflects where he ranks women in our social structure and hierarchy. It is also entirely inconsistent with the arguments that he has been relying upon in the current debate over the abortion drug RU486—that is, politicians are best placed to decide whether women should have access to an alternative termination option. But the member for Warringah’s musings at least help us to focus the debate on the issue currently before the parliament—that is, whether the Minister for Health and Ageing should decide whether an alternative method of termination should be available to the treating doctor or whether it should be a matter for the health experts to determine.

All medicines available in Australia have to be approved by the Therapeutic Goods Administration and they are approved only for specific uses. Some drugs are approved for certain uses but not for others. Mifepristone is the only drug that needs the additional approval of the Minister for Health and Ageing. Under current law, the minister is not required to tell the parliament if he has rejected an application, nor is he required to give his reasons. He is only required to tell the parliament if he has approved an application. Again, he is under no obligation to tell the parliament why, nor can the parliament reject his decision. So much for his argument that the existing system provides for greater public scrutiny and accountability.

No drug company has made an application to introduce mifepristone to the Australian market because such companies know that Tony Abbott will reject it, regardless of what the medical experts say about its appropriateness and whether or not it is safe to use. This stems from his total opposition to abortion. Yet, as I said earlier, in this country this issue has been legally settled well and truly. His position will not reduce the number of terminations taking place in Australia, of course; it will only reduce procedural choice. In the meantime, his determination to block the drug is also denying the many who seek hope in RU486 for the treatment of a range of other ailments, including those that fall under the banner of what we know as cancers.

RU486 has been approved for use in 35 countries, including the United Kingdom, the United States, much of Western Europe, Russia, China, Israel, India, New Zealand and Tunisia. Surveys in those countries show no increase in the number of terminations since the drug’s introduction.

Having studied closely the evidence submitted to the Senate inquiry, I will be supporting the bill to remove the minister’s power of veto. I will also be opposing any amendments to extend the parliament’s role in this important issue. I believe that this matter of choice is a matter for the experts.

The current debate, again, is not about whether abortion is right or wrong; we all find it troubling. It is not about whether it should take place in Australia. That, again, is a matter that has been settled by each of the state governments in every jurisdiction, where already termination is readily available in cases where a GP or specialist is of the view that continuing the pregnancy is not in the woman’s best interest.

I support the views of the member for Murray, as a member of this place who represents a rural electorate, that we must strive to give rural women better access and, therefore, greater choice in the determination of their lives and their health and wellbeing. In a country where the law is settled on the legality of abortion, women who face the distressing prospect of terminating their pregnancy should be able to choose the procedure that is least distressing in their circumstances and best for their physical and psychological wellbeing.

Jason Wood (La Trobe, Liberal Party) Share this | Link to this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. This bill, which has caused considerable public debate and strong interest from the media, is one that affects this entire country. In my electorate of La Trobe, I have been lobbied strongly by supporters of the bill and by those who strongly oppose any change to the current system, where the federal Minister for Health and Ageing determines whether RU486 should be assessed by the Therapeutic Goods Administration. The Therapeutic Goods Administration, the TGA, identifies, assesses and evaluates the risks posed by therapeutic goods. On the basis of its clinical and medical investigations, the TGA determines whether the goods are safe for use in Australia. If a drug is approved, the TGA subjects the drug to ongoing rigorous monitoring and reviews. It regulates all medicines but currently does not assess those that are deemed to be restricted goods under the Therapeutic Goods Act 1989. As a medicine that induces an abortion, RU486 has been defined as a restricted good under the act since 1996; therefore, currently it cannot be evaluated by the TGA without written approval from the Minister for Health and Ageing.

One step the TGA can currently take under the legislation is to grant approval for RU486 to be imported under its Special Access Scheme; but, unfortunately, it is the practice that this scheme is frustratingly unworkable. This is because, even if an import permit were granted, RU486 would still be deemed restricted and the TGA could not evaluate it without approval from the Minister for Health and Ageing. Without such an evaluation, the TGA cannot provide the normal assurances for drug use on which doctors depend for their indemnity requirements. In my opinion, all drugs proposed for use in Australia should be assessed and evaluated by independent medical experts and not politicians.

There are those who say that any member of parliament who supports this bill is shirking their responsibility and is not prepared to make a decision for which they were elected. A flaw in this argument is that there are very few members elected to parliament who would be regarded as experts in this field, which is why we have a TGA to medically test and evaluate the safety or otherwise of drugs. But, to greater strengthen this argument, I have canvassed those most medically qualified in this House on whether RU486 should be referred to the TGA. I have canvassed Dr Brendan Nelson, Minister for Defence, from New South Wales; Dr Mal Washer, member for Moore in Western Australia; Dr Andrew Southcott, member for Boothby in South Australia; and Dr Andrew Laming, member for Bowman in Queensland—all members from different states and with different medical backgrounds but who, in their expert medical opinion, believe that RU486 should be referred to the TGA.

If the restricted goods provisions were removed from the Therapeutic Goods Act, the TGA could get on with the job of assessing the risks involved for Australian women in using RU486, just as it does in assessing so many other pharmaceuticals. RU486 has been approved in Western countries in Europe and in the United States, the United Kingdom, New Zealand, Russia, China, Turkey, Tunisia and Israel. This drug is a synthetic steroid and is used to induce what we commonly know as a medical abortion.

Supporters of RU486 state that a woman who has made the difficult decision to terminate her pregnancy could use RU486 during the first nine weeks of her pregnancy, although she could also induce in her second trimester. The woman would visit a licensed facility, where she would be given a specified dose by a medical professional and then return two days later to be given a prostaglandin, usually misoprostal. On taking the drug, the woman can expect an experience much like a spontaneous miscarriage, as described by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Supporters also claim that RU486 is effective in 92 to 98 per cent of cases. Where the drug has been unsuccessful, a surgical abortion will be required, along with backup and medical care. Potential side effects can be internal bleeding and infection caused by retention of the products on conception. Supporters of RU486 state that the drug is a great leap forward for women from rural areas for whom medical access is often limited and also a leap forward for women with strong religious or ethnic backgrounds for whom privacy is very important.

I note that Dr Sharman Stone, Minister for Workforce Participation, who is here today from the rural electorate of Murray in Victoria, is a strong advocate of RU486 being referred to the TGA on the basis of complicated issues faced by women in rural electorates like hers of Murray when compared to inner city electorates. An article in the Medical Journal of Australia in 1997 entitled ‘Women’s satisfaction with medical abortion with RU486’ claimed that many women feel much more control over the termination process when using RU486 and that the use of RU486 does not require anaesthesia or, indeed, risk damaging the cervix.

The Australian Medical Association President, Mukesh Haikerwal, argues that RU486 is safe and has been used overseas for many years, with the successful treatment of over one million women. On the other hand, opponents to RU486 such as Chief Medical Officer, Professor John Horvath, say that when a woman uses RU486 there is a significantly higher risk of experiencing adverse effects than when she opts for a surgical abortion. The risk to women is substantially increased where they are not close to doctors or hospitals that can handle emergency complications. As I mentioned earlier, women from rural areas are a particularly good example of the types of women who might benefit from RU486, but unfortunately it is these women who often live further away from doctors and hospitals who may find themselves in these risky situations, Professor John Horvath highlights.

Opponents also claim that a number of women have died when using RU486. Currently there are investigations into these deaths in the United States. Experts will meet in May to discuss this issue. They believe that the deaths occurred because of lethal bacteria caused by toxic shock syndrome in users. Statistics regarding deaths as a result of using RU486 vary, which is why the TGA needs to examine the drug for use in Australia. With so many varying options on the risks and benefits of RU486, it is imperative that we ensure that this drug is rigorously and independently evaluated. The Therapeutic Goods Administration is the leading body to undertake these evaluations and ultimately tell us whether RU486 is safe for Australian women.

I am greatly concerned with the number of abortions in Australia. The Health Insurance Commission estimated that in 2003 there were, tragically, 73,000 abortions, compared with the ABS figures which state that in the same year there were 251,000 births. However, I also point out, as stated in 2004 by the Minister for Health and Ageing, Tony Abbott, there are no reliable figures on the number of abortions in Australia each year.

I urge fellow colleagues to support a call for more funding for education to prevent unplanned pregnancies, and of course any education must also be targeted at the male population. From memory, I have not seen any major media campaigns on trying to prevent unplanned pregnancies, or if there have been they have simply not worked and need to be changed.

Finally, if RU486 is not approved, that is the end of RU486 in Australia. However, if it is approved by the TGA, this will provide a choice for women but it will not reduce the number of unplanned pregnancies in Australia. Again, that is why I call on politicians who have been elected to make decisions on behalf of their electorates to lobby for additional funding for education on preventing unplanned pregnancies; extra funding for the counselling of women to discuss options rather than having an abortion; and extra funding for women who decide to continue with an unplanned pregnancy.

Rod Sawford (Port Adelaide, Australian Labor Party) Share this | Link to this | Hansard source

I congratulate the member for La Trobe, because I think that in the latter part of his speech he identified the core of the problem. In a free and democratic society, the control of a woman’s body ought to be self-evident. There ought to be no doubt whatsoever. The control belongs to each individual woman. To suggest otherwise is to support a society to which I do not want to belong. If a prescription drug is involved, obviously a woman’s doctor is a crucial part of decision making. If a prescription drug is involved, obviously the Therapeutic Goods Administration plays a significant role. However, in the final analysis, the choice of using either legal drugs or legal surgical procedures is for each informed woman to decide.

There are some basic fundamentals to which I believe a good society adheres. I believe in free speech. I accept that that belief can be contentious at times, but the belief is more important than the risk of overreaction by totalitarian groups. We should never forget that or be cowed by overreaction. I believe science should not be trumped by religion. Recent efforts to clothe discredited and nonsensical creationist views with so-called ‘intelligent design’ are no more than manipulative brainwashing. I believe that the beliefs and religious views of all individuals should be protected and defended. However, that protection and defence does not entitle the believer to dictate their views to others. I believe politicians ought to keep out of people’s bedrooms. The sexuality of any individual is not our business. I do not recognise same-sex marriages but I do recognise civil unions. I believe women should have control of their own bodies.

Many of the basic fundamentals and freedoms of a good society are being challenged throughout the world. Intrinsically there is nothing wrong with challenging existing beliefs, no matter what they are. Debate is healthy, but many of the challenges are not genuine. In fact, ‘attack’ describes more accurately the situation on many occasions. It has to do with propaganda; it has to do with denial; it has to do with power and control; it has to do with manipulation; it has to do with totalitarian brainwashing; it has to do with extreme fundamentalism; and sometimes it has to do with evil. Often that evil is clothed in seemingly plausible arguments, but it is evil nevertheless and it ought to be exposed and vigorously rejected. As occurred in the Senate, commonsense and goodwill will hopefully prevail on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 in this House when the matter comes to a vote—a vote to make consistent the application and approval of drugs into Australia. That is the proper thing to do: evaluate a drug as all other drugs are evaluated.

It is claimed by many that this debate is not about abortion—even the Prime Minister makes that point—and, technically speaking, that is correct, but ideologically and strategically that is not the case. Opponents of this bill are using the opportunity to debate the issue of abortion via the back door. Unfortunately, this is a de facto debate on abortion, and there can be no escape from that conclusion. The simple fact is that any debate on abortion divides all the participants into ‘for’ and ‘against’. There is no common ground and there is no consensus. A debate on abortion is totally unproductive.

A more responsible debate, as the member for La Trobe pointed out, a more honest debate, a more inclusive and unifying debate, but still a necessary debate, is the debate about how to prevent unwanted pregnancies. Is that topic on the national agenda? You bet it ain’t. The question to ask is: why? Is that notion promoted by church leaders and pro-lifers in Australia? You bet it ain’t. The question to ask is: why? In a debate on the prevention of unwanted pregnancies, no initial division of participants would occur. No-one would be excluded; belief systems would not influence the debate; past experience would be non-consequential; and emotional claptrap would be absent. Any exposition would be based on reason, substance, science, proper analysis and evaluation, rather than on style, propaganda and faith based dogma. Yes, goodwill and commonsense would be required, but that is what the overwhelming majority of Australians expect of us in this place—to subjugate our personal prejudices and our personal beliefs and replace them with reasoned argument on all matters that come before this parliament. The current worshipping of the cult of celebrity, the massive egos and the drift towards a manipulative democracy, which is practised so increasingly by people both within and outside this parliament and in the media, is largely and rightly rejected by thinking Australians. It would be quite a positive achievement to reduce and diminish that worshipping of useless activity even just by a tad.

This is not a complicated debate. The TGA is the proper body to regulate drugs—no ins, no outs; end of story. It is the current process of excluding RU486 that is flawed, not the process suggested by this bill. I also reject the amendment, or amendments, being put forward by a dozen or so pro-life government MPs. I respect their view but, from a practical point of view, their amendments are unworkable and, quite frankly, silly. The Minister for Health and Ageing was reported as saying at the University of Adelaide in March 2004:

Even those who think that abortion is a woman’s right should be troubled by the fact that 100,000 Australian women choose to destroy their unborn babies each year.

The facts to substantiate that claim of 100,000 abortions are simply not available; why would you use them? Why would you use emotive language like ‘destroy’? Certainly the health minister qualified his comments to Adelaide university students by saying that no-one wanted to ‘recreate the backyard abortion clinics or stigmatise Australians who had abortions’. But did he consider alternatives? No. Is he genuine on this matter? I do not see the evidence that he is. The current reality in Australia is that abortions are available under state laws and, overwhelmingly, those abortions are conducted under anaesthesia and with surgery. As with all procedures involving anaesthesia and surgery, some risk is involved. With drugs, risks are attached too, and RU486 is no exception. As with anaesthesia and surgery, the use of RU486 has risk.

Let no-one in this place be deluded by claims that opposition to this bill is based on anything other than pro-life, personal or religious views. I do not have a problem with that. What I have a problem with is the claim that opposition to this bill is based on reasoned argument. It is not. As an example, take the health minister’s suggestion that Australia’s medical professionals could be irresponsible in prescribing or not prescribing any drug, including RU486. Quite frankly, that is an affront to the nation’s doctors and was rightly rejected by the AMA and other doctors organisations. If an individual doctor refused, because of their own personal beliefs, to prescribe on grounds other than medical science, the patient could at least choose another doctor.

The point that was also made by the member for La Trobe that politicians are accountable for their actions and bureaucrats are not is, as he suggests as well, spurious. Approval or rejection of RU486 is and should only be a technical matter, as it should be with all existing and all future drugs that come onto the Australian market. Accountability operates as with any other drug—no exceptions; no special treatment. Let the merits of the argument prevail.

In conclusion, may I again remind members as others have done that RU486 is available in 33 other countries. Some of them tell a story by just saying the country without comment: New Zealand, the United States of America, Great Britain, France, Sweden, Turkey and Israel—and we could go on.

In supporting this bill I am not asserting the safety of this or any other drug. Like everyone in this House, I do not have the qualifications to make that decision. But I have every confidence that the Therapeutic Goods Administration in this country does have that expertise and will exercise its responsibility to the benefit of the Australian people. I commend this bill to the House.

Dennis Jensen (Tangney, Liberal Party) Share this | Link to this | Hansard source

I would like to say at the outset that I am extremely troubled by abortion, and should in no way be seen as an abortion advocate. Clearly, there are too many abortions and, as others including the member for La Trobe and the member for Port Adelaide have stated, we need more education. In addition to that, we also need to ensure that women, prior to having abortions, actually receive the counselling that they should, as is enshrined in many states. However, this is not an abortion debate. Abortion, as has been stated, is legal in Australia. So what is this debate really about? The member for Port Adelaide is correct in saying that, at its core, this debate really is extremely simple and it has been way overcomplicated.

It all distils down to a really simple premise: parliament determines whether a procedure or a treatment is legal or not, given moral and ethical imperatives. That is where the moral and ethical arguments come into play. Once a treatment or a procedure has been determined by this parliament to be legal, analysis of the methods, treatments and drugs should be up to the professional body, the TGA. If it is deemed by parliament to be an illegal procedure—fair enough; the drug does not get evaluated.

There have been numerous arguments put by members in this parliament and in the other house. For example, Senator Joyce was suggesting that, if the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 gets up, members who voted for the bill would be responsible for any deaths that occurred as a result of RU486. Quite frankly, that is a spurious argument which could be turned around. It could be said that if RU486 is determined to be safer than surgical abortion then extra women that die as a result of surgical abortion have died as a result of members voting against the bill. I do not accept either of these arguments.

I have also heard arguments about the safety of RU486. Quite frankly, these are parliamentarians’ viewpoints, where they have obtained evidence purely to support a preconceived viewpoint. This is not the way to objectively determine safety. I have also heard arguments about elected people and not faceless bureaucrats making decisions. What are we doing here? I think that elected members of parliament are making a decision on this. Elected parliamentarians make decisions about treatments and procedures; domain experts determine whether a specific drug, procedure or treatment is safe. Hence, parliament is making a decision on the moral and ethical imperatives in determining whether these treatments or procedures should be legal; the TGA is actually making a decision on expert evidence. That is an area that is best left to the experts.

If we, as parliamentarians, get into the area that is best left to experts, then there is a whole area of unintended consequences. For example, let us examine RU486. It can be used for numerous medical treatments, not just abortions. In fact, RU486 was developed by Roussel UCLAF as a treatment for serious endocrine disorders. It was not developed for chemical abortion.

Going back to the original bill in 1996, I was quite interested to read some of the comments by Senator Harradine. Senator Harradine put out a briefing note during 1996 and read it into Hansard. He claimed:

A major factor propelling the research and promotion of the drug is its ultimate use in the armoury of population controllers.

As I said, Roussel UCLAF developed it for serious endocrine disorders. I do not see the population controllers getting involved in that aspect. Senator Harradine also stated:

The question should be asked: how were those drugs brought in and for what purpose were they brought in? The drug RU486 was principally developed to be used in developing countries for population control.

Clearly this is incorrect and clearly Senator Harradine was incredibly paranoid about the issue of population control. Apart from these arguments, at the time, in 1996, I agree that bringing in RU486 might have been problematic given that in WA alone abortion was illegal. That is not of concern today.

In terms of the other uses for RU486, there are possibilities for a number of medical applications, including inoperable meningiomas, Cushing’s syndrome, breast cancer, prostate cancer, glaucoma, depression, endometriosis and uterine fibroids. I have made contact with the University of Texas, which is currently undertaking research into the effects of RU486 on uterine fibroids. I am also aware of clinical trials sponsored by the National Institute of Mental Health in the United States using mifepristone for the treatment of bipolar depression. It has also been shown to be effective in surgically intractable Cushing’s disease or Cushing’s syndrome and other progestogen or glucocorticoid secreting tumours.

Prostate cancer is the most common registrable cancer in Australian men. Each year around 11,200 Australian men are diagnosed with prostate cancer, with more than 2,700 men dying each year from the disease. Each year a significant number of women have hysterectomies due to endometriosis or uterine fibroids. How many of us are aware of clinical trials involving RU486 being carried out to look at these aspects of the drug’s capabilities? As I said, clearly we do not have the expertise and we are not aware of these unintended consequences or additional research that is carried out.

The fact is that chemical abortions still happen despite the fact that at the moment RU486 is not legal. Unfortunately, as I said, the Harradine amendments have not prevented chemical alternatives for terminations over surgical terminations. The futility of having parliament or the minister blocking the availability of abortifacients is made clear by recognising that other drugs are already used to abort. In Sydney it was reported that a doctor had carried out 60 abortions using methotrexate, which blocks folate, which is necessary for cell division. Obviously, if the embryo does not divide its cells, the embryo dies. Another doctor prescribes misoprotol—Cytotec—which is a prostaglandin. This drug induces uterine contractions and can be very painful. In other countries it is usually used as the second stage after RU486. Here it is being used as the primary method. Chemical abortions are occurring, and will occur whether RU486 is legal or not. We are currently condemning women to suboptimal treatments.

This clearly demonstrates exactly why the issue of determining whether drugs should be allowed or not is best left in the hands of experts. What we parliamentarians need to decide is whether the treatment or procedure should be legal or not. This is the proper place for that debate, with all of the moral and ethical complexities that are inherent in it. The proper place once that decision has been made and affirmed is that the TGA, the expert medical body, should be making decisions on the safety, efficacy and cost of those alternatives.

Sharon Bird (Cunningham, Australian Labor Party) Share this | Link to this | Hansard source

Having listened to the contribution of the member for Tangney to the debate on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, I appreciate very sincerely the logic that he brings to it—and will make no attempt to emulate his capacity to get his tongue around the medical terminology. I extend that same appreciation to the member for La Trobe and the member for Port Adelaide, who spoke before me.

Because this is a conscience vote, I take the opportunity to put on the public record the reasoning behind my vote. I will be voting against the amendments and for the bill. As I am sure has been the case with all members, I have had extensive lobbying from both those who are supporters of the bill and those who oppose it. I will attempt to deal with what I see as the three main issues that have been raised with me in opposition to the bill and why I do not accept those arguments.

The first and most consistent position of those arguing that I should not support the bill is fundamentally an anti-abortion argument. There is obviously a deeply held and, I believe, sincere religious belief among many people who hold a religious belief—not all, but many—that abortion is not a moral option and that we should oppose it on those grounds.

I respect those opinions. It would be a sad day indeed in this country if we could not have civilised debates about those sorts of issues. What I do reject is what I find a very offensive argument made in some of those contributions that because I do not hold a religious belief I do not have the capacity to have a moral structure in my life. That is as offensive as T-shirts that may be worn offending those of particular persuasions or what I consider to be anti-Muslim comments made by the member for Hughes.

I am of an age where I have delved through the mysteries of life and the realities of living. I have a very profound moral structure that informs my life. It informs my position in supporting the right of women to access abortion. While I appreciate that some will not agree with the conclusions that I have come to, I would ask them to extend to me respect as a person who does not hold a religious view but is perfectly capable of having a profound moral structure to my life.

The reality for people who have raised with me their concerns about abortion is that this debate and the vote will have no impact on whether or not abortion is a legal process in Australia. That is the responsibility of state governments. At this point in time, in all states, abortion is legally available under particular constraints that are in legislation. My argument to those people is that in many ways it is raising a false hope to say that this is an abortion debate. It is not. Indeed, at the end of the day, when we vote, what we are voting on is a decision that a woman with her specialist can make after having made the decision about whether or not to have an abortion.

The second level of concerns that have been raised by people asking me to vote against the bill are the safety concerns around the drug. Clearly, there is some controversy in some parts of the world. I do not intend to cover that issue at all, because I have absolutely no expertise on which to make those assessments. In this country we have legislation that determines which types of drugs are available and which are not—indeed, there are some drugs that we completely prohibit, for good reason. But when it comes to the decision about how safe and under what circumstances a drug should be available, we do leave that to the experts. I think the TGA is the appropriate place to review all the situations across the world—all the current uses of the drug, the advice of the international drug organisations—and to make a determination on its availability and the circumstances and safeguards under which it should be used. So my response to those who have argued the risk factors to me is that I think that is a perfectly legitimate argument, and a perfectly legitimate concern, but it is most appropriately dealt with by the TGA.

The final level of issues that have been raised by those asking me to oppose the bill are those about parliamentary responsibility. Many people say that, because it is a contentious issue—that is, not the use of RU486 but the availability of abortion—that the parliament, as the elected representatives, should have the final say. What baffles me with that argument is: what on earth are we doing here over these two days, if not taking responsibility for that debate, for considering how we want applications for that drug to be processed? I reject the argument that it is a failure of responsibility by the parliament in this debate to make a decision. What are people actually saying—that, in each and every case of the use of the drug, this parliament should review the circumstances of that individual case and decide whether it is a legitimate use of the drug? Of course not. Are we saying that we should review this each and every time another practitioner or organisation wants to use the drug for the purpose of abortion? In what way is that a higher level of responsibility than making a decision now about where that responsibility should lie and whether or not we are comfortable with the medical experts making a decision on its safety and efficacy?

I know there are genuinely argued concerns, and they are deeply held and passionate beliefs for many people. So I have attempted to sincerely go through the three levels of the argument and put on the record why I reject them. The options we have before us include two amendments, one second reading amendment and one consideration in detail amendment. While I appreciate the motivation behind the consideration in detail amendment, I believe there is a hidden motivation behind the second reading amendment: to gag this debate at the end of the day. I hardly think that is representative of parliament taking responsibility, so I will not support that amendment. I will not support the consideration in detail amendment that has been foreshadowed, because I think our responsibility is to make a decision now and to let the TGA get on with assessing the issues that it faces.

I am pleased that by and large in this House we have been able to have a civilised debate. I am sure that many of us have had fairly intense discussions with our colleagues, within our families and within our communities about it. I am more than comfortable that this bill represents what I have reached as a well-considered view within my moral structure of life. I will be supporting the bill.

Finally, I want to put on record my appreciation for the men in this House, across all parties, who have appreciated that this debate does have a deeper resonance and significance for women. The reality is that when many women find out they are pregnant it is a moment of intense joy and excitement. But there is a different reality for women in the physical carrying of a baby and in giving birth. I think that has been recognised in many ways in our society. The challenges of this, for some women, are also pretty devastating. If you look at the data on abortion worldwide, there are many women of varied religious beliefs, various ages and various socioeconomic backgrounds in these circumstances. I do not like to portray them as defenceless, unresourced, poor women who have no other option. I think that is a very false structure to put around it. For many of those women it is a very difficult decision; for some it is not. For those women the reality of that decision and that choice is profound. The rest of us who know what that difficulty can be feel that it is difficult to listen to people who will never actually be faced with that reality express an opinion.

I see my colleague at the table the member for Grayndler, who I thought put it in the best words: if you do not have a womb, you really cannot quite appreciate this. I think that men who reach out and try to be empathetic to those women are to be profoundly congratulated. While it should not prohibit anybody from this debate I think an appreciation and an empathy with those issues is very much appreciated. I wanted to put that on the record as well.

Peter Costello (Higgins, Liberal Party, Treasurer) Share this | Link to this | Hansard source

I would like to begin by thanking the many constituents who have contacted me, both for and against the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, and who have put their views to me. To each and every one of those constituents I have given the assurance that I would consider the matter carefully, that I would weigh the arguments and that I would take a decision after very careful consideration.

It is illegal to import, manufacture or supply therapeutic goods unless they are registered in the Australian Register of Therapeutic Goods. A person may seek to have such goods registered by making an application in accordance with requirements set by the Department of Health and Ageing. In practice, the application is considered by the Therapeutic Goods Administration, the TGA, although entry onto the register is a matter for the secretary. In order to be registered, the goods must be shown to be safe for the purpose for which they are intended and to have efficacy for the purposes for which they are to be used. This is the essence of the registration on the Australian Register of Therapeutic Goods. It is designed to protect the public from unsafe medicine, unsafe manufacture of medicine and false claims about the properties of medicine. As I have said, the entry onto the register is made by application and supported by scientific evidence. In one case, however, the procedure is different. That is the case of restricted goods. Restricted goods cannot be evaluated, registered or listed without the written approval of the minister. Restricted goods are medicines intended for use in women as abortifacients, and they include RU486. The bill before the House would remove the definition of restricted goods and leave the procedure for the registration of these goods the same as it is for any other goods to be entered on the register.

A lot of the commentary on this bill has revolved around the rights and wrongs of abortion. This bill does not affect the law on abortion. The law on abortion is set by state statutes or by state courts that have laid down the common law. In general terms abortion is legal if it is performed to prevent some serious danger to a woman’s mental or physical health. I think this is an appropriate test. I think it is now a settled test in Australian law, and I would not change it.

We all come to this debate with our own personal experiences. Our personal experiences colour our outlook on this most personal of issues. I think it is common knowledge that when my wife, Tanya, was pregnant and unconscious in hospital some 18 years ago I was faced with this terrible situation. I was advised by expert medical opinion that the pregnancy was complicating the medication she would need to survive. She was unconscious. I was faced with a choice—an awful choice—but the choice I made was to continue with both the treatment and the pregnancy. By the grace of God, both survived. But I have no doubt that the law should not have prevented such a choice, that the law should allow a choice where the physical or mental health of the woman is at risk. By the same token, I would do everything I could to dissuade people from taking abortion as a first choice. Only in those limited circumstances do I believe the law should permit it. Rather than being a first choice, I believe it should be a last choice.

I cover these issues only to restate my views and put them on the record. Again, let me reiterate. This bill is not about abortion. It is not directed at changing the abortion law, nor is it directed at changing the enforcement of that law. RU486 is not currently registered in Australia. It could be registered under the current law. It could be registered under the law as amended by this bill. But, whatever happens, the law on abortion will not change.

The issue that the bill before the House raises is the procedure to apply if an application is made. Some will say that the requirement for the approval of the minister makes it less likely that the application will be made. They point to the view of the current minister. Can I say I am totally uninfluenced by that. The minister will change. I have served in this parliament with many ministers; I expect to serve with many more. Some have been anti-abortion and some have been pro-abortion. Getting the approval of the minister would be easy under the latter and hard under the former. But the approval of the minister will change as the minister changes. What we should be doing is thinking of a process that will have integrity under ministers of different views and, inevitably, under ministers of different parties. The current Minister for Health and Ageing is a dear friend of mine. I do not consider the amendments of this bill to in any way represent a rebuff to him or his competence any more than the decision to give the interest rate setting function to the Reserve Bank of Australia was a rebuff to my ministerial capacity. The critical thing is to have a structure that has integrity and works to the benefit and safety of the Australian people.

It is said by some that requiring ministerial approval is a necessary condition to preserve the sovereignty of the parliament and keep decision making in the hands of elected officials. I am a great believer in the principle of parliamentary sovereignty, of keeping elected officials accountable and of giving them the capacity to make the decisions for which they are held accountable. But I believe this is what we are doing here. As a sovereign parliament we are taking the decision here and now, in a way for which we are accountable, for a procedure that will apply to an application to register RU486 if one should be made. If the procedure leads to a bad registration, the parliament could legislate to overturn it. The fact that the parliament, through legislation, delegates the decision does not lessen its power or its accountability, provided that the parliament retains the right to withdraw that delegation or to overturn the decision of a delegate.

Having said all those things, that leads me to conclude that a proposal to make decisions of the Therapeutic Goods Administration disallowable instruments is a proposal which the parliament could not easily refuse. I will listen to the debate carefully in the consideration in detail stage, but in principle I believe in parliamentary control over all these decisions.

I have read the Senate Community Affairs Legislation Committee report on this bill carefully. In the limited time available to me I do not have the time to go through the precise findings it made on the safety of this drug. It noted that the drug has been approved in many countries. It reported that serious complications are rare and adverse complications quite comparable with other approved medicines, some of which are even sold over the counter. There is no suggestion that this drug would be sold over the counter, nor should it be. If it were registered it would only be available on prescription from a qualified medical practitioner for treatment under close medical supervision. Any wider application would call for immediate intervention and restriction on the terms of its availability. The Senate committee reported that it could find no evidence that the availability of RU486 in countries where it is registered had led to an increase in the rate of abortion.

The main objection to the registration of the drug by those who reported against it in the Senate committee was safety concerns. In my view these safety concerns should be carefully evaluated by the Therapeutic Goods Administration. From my reading, guided primarily by the Senate committee and the evidence before it, the safety issues are not so overwhelming as to prevent an application going to the TGA if an application is made to do so.

In these circumstances I support a uniform procedure for applications and registration under the Therapeutic Goods Act and not one that applies a different procedure for one class, the class of restricted goods, of which RU486 is a part. In those circumstances and on the basis of the conclusions that I have drawn, I will be supporting this bill but make it clear that the sovereignty of parliament is such that, at any stage, if the registration or use should go outside the understandings that we have been given, parliament, as sovereign, has the right to intervene both as to the procedure and to matters following from it. In those circumstances I believe the matter can go to the Therapeutic Goods Administration and I will support the bill as it stands.

Harry Quick (Franklin, Independent) Share this | Link to this | Hansard source

Before I start my speech, can I compliment the Treasurer on his superb speech here this morning. It is a wonder that we do not have more conscience votes, because we have to speak from our heart, examine our soul and look at all the options on a very contentious issue. In his speech the Treasurer has done that, and I admire him for his frankness and honesty in dealing with a very complex issue. I want that on the public record.

Like everyone in this place, I have been inundated with emails both for and against this issue. As past President of the Parliamentary Christian Fellowship and now the Secretary of the PCF, it has been interesting. We had our breakfast this morning and the first topic of conversation before we said grace was the whole issue of RU486 and the different points of view. I know members in the PCF and members generally have thought long and hard on this issue. It is not an easy issue. There are no party guidelines to carry you through in a comfort zone. When the whips call the numbers, they will not have a role in this, as they did not have a role in the euthanasia debate. I supported the Andrews amendment on euthanasia, and I know it caused some angst in my family.

As people have said, we are elected here. There have been 1,018 members of the House of Representatives since 1901. We are a privileged group of people. We carry an enormous load on our shoulders. When people expect us to make decisions, we do not make them lightly. Those of us who are here—in most cases, not for a very long time; those who serve more than three terms are the exception to the rule—do look with great honesty at the issues. I know for a fact that quite often I am at discord with my party on some issues, particularly in the area of the war in Iraq. My pacifist views have got me into lots of trouble.

I am somewhat upset by the extremism in this debate. Whenever the ‘a’ word is used in this place and in the media, there are two extreme points of view. As a male, and as a member of this place, when it comes to issues of women’s health and safety and procreation, I do not have the temerity to impose my views. I have two wonderful daughters, Sarah and Hannah, and I have obviously discussed the issues with them and with their mother. I guess, being a member of the PCF, there is an expectation that I am a devout Christian and understand the words in the Bible. It worries me that there is a sense of fundamentalism creeping into this debate, which I think clouds the whole issue.

As the Treasurer said, in parliament we delegate. We have set up departments, and ministers are responsible for the conduct of those departments. For the last week on this side of the House we have been examining the conduct of departments and agencies that are under the control and purview of this wonderful place.

This is not an easy issue. We have heard about six women in the US dying after they were given RU486. We have heard of Canadian and European examples. Of course we are concerned. I rely on an insert in one of my arteries to keep me alive and I take a little pink pill every day to make sure that my blood is thin so that I can survive. When I was asked about whether I wanted to do this, I was told, ‘There is a one-in-five chance of having a stroke if you do this, that or the other.’ Of course I am concerned about medical responsibility, the use of drugs and the like—we all are. Those of us who are lucky enough to serve on the committees that examine this issue do so with great foresight and insight. We listen to the experts. As with all issues, you can listen to scientists on one side and scientists on the other.

As I said at the outset, I welcome the opportunity to listen to the points of view of the 150 members in this place. It is interesting that the galleries are a lot fuller than usual today, as they were yesterday—and they will be tomorrow when the vote is taken. People are concerned. I oppose the two amendments because I think they muddy the water and cloud the issue. I have great respect for the member for Lindsay and the member for Bowman—one has been here a little longer than the other. I know they put forward these amendments in all good faith. But, as the Treasurer has stated, we have a responsibility in this place, and we have delegation. The TGA is an excellent organisation. It has the very difficult task of regulating the whole issue of therapeutic goods. I look forward to listening to the debate. At this stage I am going to vote against the two amendments and support the bill.

Kay Hull (Riverina, National Party) Share this | Link to this | Hansard source

There is a need in this debate on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 to counter a range of misrepresentations about the history of the use and about the safety record of the drug RU486. There has been an enormous amount of debate in the House on this issue and there will continue to be. Some of it will be enormously repetitive. Unfortunately, that is the nature of this debate.

This debate is concise in its intent. It is to determine if a member of parliament—a single member of parliament of any political persuasion—should decide on the safety of a drug or whether the TGA, the body that assesses all other drugs, should be the responsible determinant. There is an important significance in separating politics from decisions on the safety and efficacy of medicines and decisions on the establishment of selective criteria and guidelines for the use of medicines. All decisions regarding medical evidence and safety measures et cetera on any drug should be made on the basis of expert evidence, not on a possible political agenda. This does not mean that the current minister’s capabilities are at all in question here. I personally happen to think that Minister Abbott is one of the best health ministers that the parliament has ever had. I have been consistent in advising him of this. But what would happen should Minister Abbott not be the health minister? Imagine having a rampant and pro-choice health minister from any side of the parliament who could make such a drug available without a clear and transparent scientific assessment process. I suspect that we would then face calls from our constituencies right across Australia to have an independent authority that is charged with the responsibility for the assessment and approval of this drug.

Since 1989 the TGA has fulfilled all of its roles in assessing and monitoring over 50,000 serious drugs. Some of these drugs are very toxic and they are made available to all Australians. With improper use they can be detrimental to people and can certainly cause death. The TGA has also responsibly refused some of the applications to make drugs available, due to its rigid and strict assessment and public health protocols. I have certainly been involved with the TGA processes in my quest to have a naltrexone implant trialled and made available for those people who are addicted to heroin. A naltrexone implant should have its safety and efficacy proved or not proved, rather than a decision being based on the hype and emotion about the possibility that a death which occurred in trials some time ago may have resulted from taking an oral naltrexone tablet.

We as a government have relied on and accepted the TGA’s advice on all other contentious pharmaceuticals. We have accepted their rigorous process. We have accepted that their scientific analysis and evaluation is a right and proper process, yet we do not accept it for this drug. One thing that should be discussed in this debate is just how an evidence based evaluation of a drug’s safety can put women at risk. This is about an evidence based evaluation, and I do not see women being put at risk by an evaluation process.

The question is just why we should not be entitled to have the weight of medical evidence considered so that we have a factual judgment about the risks associated with a drug, rather than the ill-informed, emotional, misrepresented hype that we are currently experiencing. I can honestly say, as others have said in this House, that I have never before been exposed to so much misinformation on any issue that I have had to make a decision upon. I do not blame the people who are relying on this misinformation, because they simply do not have access to factual accounts. They are being substantially influenced by this misinformation and propaganda campaign, and this is very unfortunate.

I am not at all asserting that people would agree with this bill if they were aware of the real facts. Of course they would not, as it is clearly for many an issue about the abortion factor of RU486 and their genuine objection to abortion under any circumstances or by any means. I, for one, respect the right of all of these people to hold this view. However, I do not believe that we are debating the rights or wrongs of abortion.

I understand that many people in the Riverina will be bitterly disappointed—they are bitterly disappointed; they are advising me of that—with my decision to support the bill as it stands before us. That saddens me—not because I am worried about my votes at the next election, because I absolutely accept any decision at the ballot box. If I am voted in, I will always give 100 per cent effort. However, if I am not voted in, I have a wonderful life to lead, with a wonderful husband, children and grandchildren, and some day I look forward to leading that life. Yet I do still feel sad, because I genuinely care very much about the many views of the constituents across the Riverina. To know that many will feel that I have not done the right thing in this debate does fill me with sadness. But, as I said, it is not because I am seeking their vote; it is because I genuinely would like to do the best that I can in my representation on their behalf.

Of course, there are those who are making personal judgments on my morality, and this I absolutely object to. There has been so much hype and emotional blackmail fired at me that is totally out of line and unacceptable, and I feel that I have exercised great tolerance of the accusing abuse, simply because I can understand why people get upset on an issue that may see a woman making the decision to terminate a pregnancy. But I do not feel that anyone has the right to judge me for doing the job that I was put here to do—that is, to weigh up all of the factual evidence I can, to make a decision and then to have the courage to stand here and be counted.

So, if you believe that I have taken the wrong stance and because of that you have no confidence in my representation on all other areas to do with the Riverina and its issues, I accept that. I absolutely accept that, and I have no argument, nor do I have any defence. However, I do not believe that anyone has the right to judge my morals. There is only one maker that I am answerable to, and I have no concerns about that day.

I will make reference to my view on abortion, lest it be said that I tried to hide from this issue by asserting that this debate is not about abortion. I do support a woman’s right to access a termination if she finds herself confronting a situation that, by the grace of God, I have never had to face. I have so much in my life to be grateful for, and this is one decision that I have been spared from making. I have seriously thought about it over the last few months, and I have asserted that it is a decision that I could not personally make. But, in a conversation yesterday, it became apparent to me that I could not say that, because I would not know the decision that I would make until I had actually been placed in that position.

It is obvious that my age means that I will never have to make that decision, but I will certainly not make judgments for those who may make this decision. What I will do is cast a vote to put the assessment of the safety and efficacy of RU486 into the appropriate place, in order that the rigorous analysis that the TGA employs on all other drugs can be applied. Should that assessment pass health and safety tests, then it is up to others to determine for themselves whether they will ever access that drug. I would hope that the decision to terminate a pregnancy would be a last resort and the very last choice that any woman, her partner and their families have to make. However, I firmly believe that, whilst it should be the last choice, nonetheless it should be a choice.

I would like to dispel another misunderstanding by the people who are claiming to me that RU486 is a do-it-yourself abortion procedure that will see the purchase of RU486 over the internet and almost without question. They are absolutely wrong. Medical abortion is not a do-it-yourself option. The facts are that you need to comply with the abortion laws of the state where you reside and that, whether it is a medical or a surgical termination, it requires medical oversight and approval. If a state requires the satisfying of mental health or physical tests or any other reason for a surgical termination, the same conditions will have to be satisfied, should this product be proven, available for the market and able to be utilised for a termination.

Another factor that needs to be considered in respect of RU486 is the benefit it brings as a treatment for inoperable tumours and cancers, including breast cancer and prostate cancer. Whilst there is a claim that RU486 has claimed lives, and that is true, it must also be said that RU486 can save lives, and that is also true. It has been stated in correspondence to me that RU486 is currently approved by the TGA for those illnesses but, factually, that is not correct. The Secretary to the Department of Health and Ageing acknowledged only last year that only a very small number of cancer patients had gained any access to RU486.

I again remind the House that, although I feel compelled to address the issue of abortion in this debate, simply because the debate has been hijacked towards this area, I am only charged with making one decision. That decision is about the correct procedure for all drug assessments in Australia. I assert again that my vote is nothing to do with a vote of no confidence in Tony Abbott, the Minister for Health and Ageing. In fact, it is a vote of no confidence in the procedural position that we have found ourselves in.

I have been emotionally hit by the contributions of member after member, who have stood in this parliament and emotionally outlined their justification for doing the job they were put here to do. This issue has had members reaching into their past, their present and their future. Members have questioned themselves—many to the point of exhaustion at times—and it has hit me that there are far too few people out there in voter land who really have any idea of the difficulty in terms of commitment that members of parliament face. I am proud of each person who has stood in this parliament on this debate, no matter what decision they have come to, because I know that each of them has put themself through a personally confronting process in order to come to their position. This is what true democracy is all about. I support the bill as it stands in the parliament.

Peter Garrett (Kingsford Smith, Australian Labor Party, Shadow Parliamentary Secretary for Reconciliation and the Arts) Share this | Link to this | Hansard source

I rise in support of the comments of the member for Riverina and others in the House and in support of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. As this debate allows for a conscience vote of members in this House, I do not claim to speak for all the people in Kingsford Smith—some are opposed to this bill and some are in favour of it. In this instance, I only claim to speak for myself, and I say to the people in Kingsford Smith that I have thought long and hard about this issue and I hope they understand my reasons for coming to the decision to support the bill.

Primarily my reason is a simple one, and it has been stated by others. I do not believe that the bill before us is about abortion at all, although the debate surrounding the bill has understandably expanded into that domain. This bill concerns the appropriate way for a drug to be regulated and approved, and it is on that basis—on the substance of the bill itself—that I have come to the view that I should support it. I believe that the question of appropriate drug approvals and regulations is separate and distinct from broader discussions about the merits of the matter, which go to questions of belief and values—factors that are important for me but which are not the nub of this debate or this legislation.

For those many Australians who have strong concerns about abortion—and I share some of those concerns, albeit from my own perspective—I think the issue properly turns on whether or not the approval of a drug of this kind would automatically increase the number of abortions that take place in Australia and would expose women to additional health risks. On a thorough reading of the available evidence and on consideration of the points that have been brought to this debate by other members—and by senators to the debate in the Senate—I do not believe that this will be the case. As the member for Riverina properly said, what should concern members is that this debate is about an evidence based evaluation of whether or not there is a safe drug available for women who are considering this most serious of matters.

I listened carefully yesterday to a number of contributions honourable members made. I acknowledge the depth of feeling in the House. I thought the arguments and the views advanced by the member for Murray in support of the bill were well made. I note too that the bill has come to us as a bipartisan bill. It has come from women senators, and a majority of women in the Senate voted in favour of that bill. I note too that medical practitioners with medical expertise within the parliament are speaking in favour of the bill. It is true that some are speaking against it—and, in terms of the respective amendments that are before us, I believe they would only add more confusion and more layers to what properly ought to be a fairly straightforward decision: that is, what is the most appropriate body to provide the regulatory framework and the approvals framework for a drug of this kind. It clearly should be the Therapeutic Goods Administration.

I confine my remarks to that observation, recognising and appreciating that the level of concern in the community on these issues is strong but stating very clearly from my own perspective that this primarily and importantly should be a debate solely about the best method of approval of a drug of this kind. To that extent and even more, I support the bill.

Graham Edwards (Cowan, Australian Labor Party, Shadow Parliamentary Secretary (Defence and Veterans' Affairs)) Share this | Link to this | Hansard source

Like others in this place, I have listened intently to the debate and to the various arguments put by both sides of the House since the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 was introduced yesterday afternoon. I have always publicly opposed abortion and have voted according to my beliefs and my conscience as a member in a state government in a previous political life. Of course, the question of the legality or the availability of abortion is one for the states.

As others have said, this is not a debate about the legality or availability of abortion. This is a debate about a restricted good, a restricted drug. It is a debate about who should be responsible for the evaluation, listing, registration or importation of that drug, RU486. The argument here is whether this drug should be assessed by the TGA or whether the responsibility should remain the prerogative of one person, being the minister for health.

I agree with many who have spoken in this debate who have said that there are far too many abortions in Australia. I agree. That is a concern that I share with them. It is interesting to note, then, that while we may agree that there are too many abortions in Australia there is no evidence at all to suggest that the incidence of abortion in Australia would rise if we were to support this bill. Indeed it has been pointed out in the course of the debate that in other countries where RU486 is available abortions are lower in number than they are in Australia. We should ask the question: why is that the case? Why is it that other countries have a far lower rate of abortion than we do here in Australia?

I suspect that it has a lot to do with the issue of proper sex education. It seems to me that for too long in Australia members of parliament, state and federal, have been running scared of those people who come out and criticise and threaten us whenever it is considered that we should turn to a more enlightened sex education being taught in our schools and whenever it is suggested that we should run more public, higher profile campaigns on sex education, on the practice of safe sex and on the practice of prevention. I think it is time that we really did focus on some of the things that are being done overseas. It is time that we had a good, hard look at why it is that other countries seem to be able to do these things much more successfully. Indeed, it is time that we brought the debate out of the dark and into the light. If we are going to lower the incidence of abortion in Australia, these are the things we simply must do.

The question is whether the minister should be the one to make the decision in relation to this drug or whether this is a decision that should be taken by a woman in consultation with her family doctor. If it is the latter, as I believe it should be, then that doctor and that woman should be able to take the decision based on the knowledge that this is a drug that has been properly evaluated by the most appropriate people. Of course the most appropriate people are those with the training, the knowledge, the experience and the expertise—they are the people who make up the TGA.

In making up my mind as to how I would vote, I have listened to the arguments. I must say I have largely been swayed by the member for Moore, in Perth, Dr Washer. The seats of Moore and Cowan are joined. I have a fair bit to do with Dr Washer from time to time. I listened to his speech when he introduced the bill yesterday afternoon and I thought he did an excellent job in the way he presented the arguments and in the way that he set the scene for this debate. I was also very impressed with our own Julia Gillard when she responded in a like way. I think between the two of those people they have set the scene for a very mature and even-handed debate. Dr Washer, when he was a GP, was my mother’s doctor when she was aged and when she was quite ill. She had a great deal of respect for his judgment, and it is a respect that I, too, have and want to acknowledge. I have been swayed by Dr Washer and I thank him for the way that he has presented his arguments in this parliament.

I have also received many emails and a number of letters, just as every other member in this place has. I have had many phone calls in my electorate office and of course over here in Canberra. I have listened to the arguments that people have put. There are many arguments on both sides of the point—many arguments for, many arguments against. But there can only be one vote. That is my conscience vote. I will be supporting this bill. I will not be supporting the amendments. I will support the bill as it stands.

I just want to quote one of the many emails that I have received because, for me, it really has summed up the pertinent points of this argument. It says:

Dear Graham Edwards,

As a member of your electorate and a labor voter—

I might say that this could just have easily been a National Party voter or a Liberal Party voter; that is not the point—

I am emailing you because the Federal Parliament will soon be deciding whether a politician or health professionals will determine access to the drug RU486. used to treat serious illnesses including cancers and brain tumours and to terminate early pregnancies. While this issue has become the subject of heated debate about abortion I believe that the greater issues here are whether medical professionals or politicians make such decisions now and in future, and the rights of Australian citizens to choose their medical treatments from the full range available. Clearly the way in which the legitimate use of RU486 in varied applications has been prevented solely on the grounds of personal views of politicians regarding a single application of the drug, makes it clear these decisions are more appropriately made by health professionals. I therefore urge you to make your vote on this matter mindful that this is not simply a vote for or against abortion but one encompassing far greater issues affecting the rights and freedoms of all Australians. I ask you to vote to remove the health ministers veto on RU486.

Yours sincerely ...

and we do not need the person’s name. As I have said, I have read the emails and the letters and I have listened to the phone calls; I have evaluated them. I have listened to the debate. I feel very comfortable in my decision to support the bill, for the reasons largely set out by one of my constituents.

Michael Johnson (Ryan, Liberal Party) Share this | Link to this | Hansard source

I am very pleased and very honoured to have the opportunity to speak in the House of Representatives, as a member of this parliament and as the representative of the people of Ryan but on this occasion also in my own capacity just as Michael Johnson, a citizen of this country. I am pleased to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005.

This is the second occasion on which I have been given the opportunity to speak on a bill in the parliament where the Prime Minister has allowed a free vote or a conscience vote; the first was the Research Involving Embryos Bill 2002. At the outset, I express my thanks to the Prime Minister for affording individual members and senators this opportunity. Indeed, my own view is that this parliament should perhaps have more opportunities for free votes or conscience votes; but that is a debate for another day.

I also want to declare my personal respect for and understanding of the views of all my colleagues in the parliament. I know that this vote is very difficult and confronting for many of my colleagues in the parliament; for others, that may not be the case. I also want to thank the hundreds of Ryan residents who have taken the time to call my office, to email me or to write to me expressing their personal views. Almost all those who have taken the time to contact me have expressed their views, one way or the other, in no uncertain terms. In all cases, I have welcomed their contact very much.

As for my own position, I have expressed it publicly and privately. I will be supporting this bill in its current form. I will be voting for the passing of this bill here in the House of Representatives chamber. I will be voting to take away from the Minister for Health and Ageing responsibility for the approval of this drug. In holding this position, I am comfortable with this decision, I am at peace within myself and my conscience is clear and strong. I am comfortable in supporting and voting for this bill, both as a citizen of this country and in my professional capacity as the elected representative of the people of Ryan. I will be voting in favour of this bill, irrespective of the position of those who have lobbied me one way or the other. I know that with my vote I will be angering and deeply disappointing the views of many Ryan residents. Equally, I know that by voting in favour of this bill I will be pleasing many other Ryan residents whose views coincide with my own. To me, this is not the point, as this is a conscience vote.

I believe that, this being a conscience vote, it is incumbent upon me nevertheless to try to explain the reasons for my position; I believe I owe that to my electorate. At the outset, let me say that any abortion or termination of pregnancy is deeply regretful and deeply sad. One abortion is one too many. As far as is humanly possible, we must do all we can in this country to minimise the number of abortions there are. As members of parliament and as a national government, we must do all we can to educate our citizens, especially our young people, about the implications of termination. We must step up and make uniform in our schools across the country the content of our sex education. While this alone will not eliminate the number of abortions there are, surely it will have some positive impact. Surely it will help some young Australians in the future to prevent situations where unwanted pregnancies might arise.

I want to reiterate the fundamental legal position on abortion in our country. As the law stands today, in February 2006, abortion is legal in certain circumstances in the states and territories of Australia. It should also be made clear that abortion in this country is entirely a matter for the state parliaments of this country. Therefore, this bill is not about the legality of abortion per se. In all the intense lobbying and the strong and emotional debate, I have found this fact to have been overwhelmingly ignored. If we want to change that position, we can have a debate about the legality of abortion. However, at this time the position in this country is clear. We have had the debate about legality and I am disappointed that some colleagues and many in the community have tried to portray the current debate as an abortion debate; we had that debate three decades ago. This bill is not about making abortion legal or illegal.

Due to time restrictions, I will restrict my remarks to dealing with what I believe is the central issue in this debate. In my view the central question which confronts me in this issue is: who is best placed to make the decision on the usage of the drug RU486? This is the fundamental question. Is the health minister of the day best placed to make this decision or is it another individual, another organisation or another body—in this case, the Therapeutic Goods Administration, the federal government’s regulator for drug approval?

In my view this issue is not about politics; rather, it is about health. This issue to me is entirely about the health and the wellbeing of the individual woman in question. It is not about health policy or the government’s management of health issues. It follows, therefore, that in my view the health minister of the day is not the best person to make decisions in relation to this drug and its approval. I want to echo the sentiments of my colleagues in terms of the current health minister, the Hon. Tony Abbott. This is not about a vote of confidence in the Minister for Health and Ageing. Indeed, I wish to say unequivocally in the parliament that, in my view, Mr Abbott is doing a splendid job. He has my complete respect and my support as the nation’s federal health minister. Rather, this bill asks me to determine in good faith whether a politician or a health professional is better placed to decide on the suitability of a drug for usage by Australian women. In this counterbalance, surely professionals are better placed to make the decision, not members of parliament or an individual minister.

If it is not to be the health minister, who should be giving the approval for the use of RU486? In the context of this bill and this debate, the alternative of course is the TGA. The TGA has probably never received so much attention or publicity than it has in recent weeks. In my view the TGA is a world-class organisation and Australians should be proud of its international reputation. The TGA is a unit of the Australian government’s Department of Health and Ageing and is the expert body that should be charged with the responsibility of overseeing the approval of drugs such as RU486.

I do understand that one of the strongest reasons given by those who do not support this bill is to contend that, by giving the TGA the responsibility to determine approvals, the parliament would lose accountability, that somehow the government and the executive would be subservient to the TGA, to health professionals or to like-minded organisations as an extension of government. With the greatest respect to my colleagues who assert this position, in my view this view simply does not wash. By investing the responsibility of making approvals in the hands of the TGA, we do not in any way whatsoever diminish the standing or the status of the Australian parliament. We do not diminish the authority, the prestige or the accountability of the executive, the minister or the parliament. The parliament in our Westminster system will always remain supreme in this nation. It is the parliament which ultimately gives the executive and the Prime Minister the authority to govern this country.

From time to time every government delegates its authority to agencies, to tribunals or to other bureaucrats who have professional knowledge or expertise in a particular area. We have all kinds of tribunals and panels given huge responsibilities and powers to make decisions which governments or ministers feel are inappropriate for them to make or which they feel they should be at arm’s length from. Immigration tribunals are a good example, and I only give that one example due to time restrictions. I reiterate that at all times the parliament of Australia remains the ultimate legislative authority in this country and has the right to revoke any decision or law it has previously made.

While I understand that research into RU486 has shown that it can be used successfully in the treatment of a range of illnesses—including, as I understand, brain tumours—there can be no mistake that in the context of this bill and this discussion this drug is all about a particular purpose. The debate is about the approval of the drug RU486 and its application to the termination of unwanted pregnancies. Many people believe that human life begins at conception. I respect very much those who hold that view. I do not personally believe this to be the case. Some have argued passionately that this bill will promote more abortions in this country. I do not accept this view either. I cannot bring myself to accept that a woman would determine to have an abortion lightly. I am sure that some would make that decision more lightly than others but surely not with ease or indifference. I am sure that those decisions would remain with those women for the time of their natural life.

In the debate on this issue, I have found some of the presentations by my colleagues troubling in their personal attacks and in the way they have cast aspersions on opposing views held by other colleagues. In a conscience vote there must be complete respect for and appreciation of the views of others. In a conscience vote there is no call to accept the views of colleagues, but there is a call to respect and understand the views of colleagues. Clearly a diversity of opinion will emanate from within one’s own party, as will be the case in this debate. Some of the debate has been emotional, and that is clearly understandable, but some of the remarks of some of my colleagues have been truly unbecoming to their office and status as members or senators of the federal parliament. I regret that some colleagues have tried to create maximum attention for this issue through political cheap shots and stunts.

The decision a woman makes to terminate a pregnancy is surely a deeply personal one and a terribly difficult one. It must surely be one of the most heart-wrenching and traumatic decisions a woman can make, either alone, with her partner or with her family. I can only imagine what it would be like to have to confront such a decision. It is my prayer that I will never have to confront such a decision. However, in this debate it is my view that ultimately such a decision should be the decision of the woman. It must be based on her own circumstances and life situation, not coloured by the politics of the times or constrained by the beliefs of individual members of parliament. Where the law of the land has already deemed that the termination of pregnancy in certain circumstances is legal, it is incumbent upon us all to make it as safe as possible for that woman. As I speak at this time, in my view the safest way of approaching this issue is for the TGA, the federal government’s own body of experienced medical professionals, to assess all possible medical alternatives, including the drug RU486.

In conclusion, I want to express again my thanks to those in my electorate who have contacted me to express their very deep and very personal views on this bill. I also want to compliment my colleagues from both sides of the House and on both sides of this issue who have taken it upon themselves to conduct this debate in a mature and respectful manner. There is nothing inconsistent with holding very strong views and being able to present those views in a passionate but respectful fashion. There is absolutely no need or place in the Australian parliament for members and senators to express their views in anything but a respectful and courteous fashion.

I began by saying that coming to this decision will be very difficult for many of my colleagues. Again, I take this opportunity in the parliament to express my respect for the views of those colleagues on this issue. Due to the often difficult decisions that governments and members of parliament have to make, we are often portrayed in the community and by the media as callous or indifferent. Of course, as a member of parliament I absolutely repudiate that view, and I hope very much that all members and senators stand shoulder to shoulder with me in rejecting a view that demeans the parliament and demeans the status of the office we hold as representatives of the people.

I would like to think, therefore, that this debate has revealed a more human side to those who serve in this parliament. In particular, some of our colleagues have revealed compelling accounts of personal experiences. I say to them: I salute you; I admire your courage and hope that as a national parliament we are stronger for those revelations. For these reasons and others, which, unfortunately, time does not permit me to go into, I commend the bill to the House.

Arch Bevis (Brisbane, Australian Labor Party, Shadow Minister for Aviation and Transport Security) Share this | Link to 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.

John Forrest (Mallee, National Party) Share this | Link to this | Hansard source

Let me declare from the outset my position on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I am opposed to the bill. I want to briefly explain my position to my electorate, many of whom, I know, are listening very keenly to the discussion we are having.

People have argued that this is not a debate about abortion. I understand that, but the reality is that it is. I will be saying more about that. There are a large number of Australians who are very uncomfortable at the direction the nation has taken. I do not accept the proposition that the debate was had 30 years ago or that it is not appropriate to continue the discussion.

Issues like the ones to which this bill relates are never easy. Members of the community have strong views on either side and are not backward in expressing their point of view. It is an interesting experience when issues like this arise—issues of great moral and ethical import. We see a bombardment of mail, both electronic and by the conventional method, which is simply incredible. There are literally thousands of emails—a very large number from my constituency. I saw this in regard to the discussion we had on euthanasia. I saw it in regard to the discussion the chambers had on cloning and stem cell research. I even recall the first time the parliament considered the very matter we are discussing now, way back in 1996. It certainly arouses the passions.

I have tried to keep an open mind and put my personal convictions about the sanctity of human life aside. I have tried to listen fairly to the propositions being put. But I do declare a deep-seated conviction about what I believe as the empirical truth—that we are all, each of us, nine months older than we give ourselves credit for. I am very much pro-life. But let me put that aside for the moment.

The proponents of this bill argue strongly that the decision on a restricted good like RU486 should not rest with the minister. They argue that the Therapeutic Goods Administration should be the final arbiter for approval for mainstream community use. But in dwelling on that matter, it has to be said that RU486 is no ordinary drug. It is different from the other drugs that come under the jurisdiction of the TGA. By its very name, the TGA is about therapeutic goods—that is, research and the approval of drugs which make people well. That is, after all, the Macquarie Dictionary’s definition of the word ‘therapeutic’: ‘relating to the treating or curing of disease’. RU486 is just not another drug in that context. It is a drug which destroys human life. And human life, in the expectation of many Australians—the great bulk of Australians—is life. The drug is designed to terminate a pregnancy. I would not have thought of a pregnancy as being an illness or a disease. Let us get that clear: this is no ordinary drug, and it certainly should not be considered as a medicine.

As I have also said—and I have been part of a very strong community discussion, certainly in my own constituency—people hold strong views. In that context, I think it appropriate that a restricted good like this enjoys the supervision of this very chamber and those who are represented here. It is appropriate for an elected, accountable person to be the final arbiter—despite the views of those who argue that the debate about abortion in the nation is over it is 30 years old. I believe that the great bulk of the Australian community expect that.

The proponents of this bill argue very strongly that this is a discussion about process, not abortion. I have considered that point and dwelt on it. However, it is impossible to reconcile a proposal on decisions with great moral impact—on matters on which Australians are evenly divided, fifty-fifty, and where they have indicated that they are very uncomfortable with the very issue of abortion. For the decisions that contain that kind of strong medical ethics import, the parliament and the officers who are part of the parliament should be the final arbiter. As much as we appreciate the great work of the TGA and the medical community in regard to medical advancement and the contribution they make to good health and wellbeing, they are not accountable to the community in that strong sense.

I have been somewhat staggered to see the comments of supporters of the bill. In the Senate inquiry, Reproductive Choice Australia, which is a very strong pro-abortion group, gave evidence that politics has no place in medicine. I am astounded at that, especially when I think of just how much time is consumed in the discussions that we as members of parliament have in assessing and deciding on appropriate health policy. It comes down to the position that competency on an issue of moral and ethical significance appropriately rests with the parliament and its representatives.

Getting back to the point about whether this discussion is about abortion or not, if the discussion is not about abortion, what is it about? We are discussing an abortifacient, a drug that is designed to create an abortion. Of course it is about abortion. It is about a drug designed to make that process more accessible and more convenient. It is a little too cute. I have had too much trouble trying to come to grips with the suggestion. My community happens to regard it as a discussion about abortion.

The other thing I have been trying to do is to listen to my constituency, in a genuine effort not to impose my own pro-life position. I said from the outset towards the end of last year, when this discussion first started across the community, that I thought the sentiment of my own constituency would be fifty-fifty on the general issue and that at that stage the challenge was to choose between democracy and conscience. I have come to the position that I have chosen the latter. It is always very difficult to get a handle on these things, but I believe from the mail in my electorate—and I have differentiated between the electronic and the ordinary mail from outside my electorate—that the position is 60-40 in favour of maintaining the status quo.

I also take note of some national surveys. According to an article by Fleming and Ewing entitled ‘Give Women Choice: Australia Speaks on Abortion’, published by Southern Cross Bioethics Institute last year, 87 per cent of Australians are seeking a reduction in the number of abortions in this country. That is an indication of their level of discomfort with how many are conducted. We are having a discussion here about a drug that will not achieve this objective.

I also note another opinion poll conducted in August/September last year that produced some very interesting results. I have a copy with me. It is entitled ‘What Australians Really Think About Abortion’, published by the Australian Federation of Right to Life Associations in February this year. The findings were that 51 per cent of 1,200 Australians interviewed did not support abortion for financial, social or non-medical reasons and 54 per cent believed that abortion involves the taking of a human life. Whether or not those proponents of the bill argue it is not about abortion per se, the reality is that the perception in many Australians’ minds indicate their discomfort with the whole issue. So I conclude that my original assessment of around fifty-fifty is about right. Those 50 per cent of people opposed to the bill deserve to have their voices heard in this chamber. That is what I am attempting to do.

I would like to make one final point. I want to indicate how curious I find the position that, while our Australian parliament is now wrestling with the issue of deregulating the approval of this drug, the US House of Representatives is wrestling with ways to ban, or at least regulate, its use in the United States after some very tragic outcomes there. It is an interesting observation.

The previous speaker, the member for Brisbane, did mention some serious questions about the safety of this drug. I am not convinced either way. That is not the central issue for me; I am focusing entirely on the conscience of a large number of Australians who have very strong views on this matter. I believe that, on issues containing such core moral and ethical import, it is quite proper and right that the accountable members of this place reflect that view.

One thing I would like to see is a renewed discussion, given the direction that abortion has taken. It is estimated, for example, that there are 100,000 children aborted every year in Australia. We do not even have a good handle on that figure, yet here we are discussing a so-called medication that would make such procedures even more accessible with adverse circumstances that we just do not know.

I will conclude by commenting on the number of amendments offered, which I am considering. I will do that as they arise. But, at the end of the debate, I favour the final arbiter being the parliament, its elected members, in particular the persons in the executive that the current legislation prescribes, to be that final arbiter. I think the huge ethical issues associated with this matter warrant such a position. I am opposed to the bill. I commend all members. I am grateful to be part of a genuine discussion where all points of view can be respected.

Ms Julie Bishop (Curtin, Liberal Party, Minister Assisting the Prime Minister for Women's Issues) Share this | Link to this | Hansard source

The debate we are having here today on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is not about whether RU486 is a good drug or a bad drug. It is not an opportunity to reconsider the legality of abortion. It is not about the number of abortions that take place every year in Australia. I expect that most if not all people in this place regret deeply the number of abortions undertaken in this country each year. Indeed, most people regret the difficult and profoundly disturbing decision some women make to bring a pregnancy to an end, whether for personal or medical reasons.

A broader community debate perhaps should take place on our high rate of teen pregnancy and whether we need more responsible contraception or sex education that is early, sensible, appropriate and thorough; more counselling for women who are pregnant; or a greater emphasis on adoption. These are all matters that should exercise the minds of thinking members of our society and a broader debate may well trigger a change in social attitudes or a change in community expectations.

But let us not confuse the issue. This debate is not whether abortion should be allowed. This country’s laws permit abortion in specified and regulated circumstances, and there is no proposal by any state, territory or federal government to change these laws. Put simply, abortion is legal, subject to restrictions. Let us make it as safe as it can possibly be. There are health risks associated with drugs. There are health risks associated with pregnancy. There are health risks associated with a surgical abortion, which involves extremely delicate procedures inside the uterus, with small but real risks of perforation, infection or haemorrhage. It is performed under general anaesthetic, which has its own risks, including death.

In the triennium 1997-99 there were 90 maternal deaths from pregnancy complications in Australia. There were no deaths from terminations for the same period. If there is another way, a safer way, with risks lower than surgical abortions, should not that option be available to a woman on the advice of and supervised or monitored by her medical adviser? If that safer way or that other option is a drug, should there not be a consistent, reliable assessment procedure to determine its safety and efficacy? Or should a woman have to place her reproductive health and risks to her health in the hands of one politician, albeit a minister of the Crown? The debate we are having today is whether the power to evaluate, approve and register an abortifacient is ultimately one which rests with the Therapeutic Goods Administration or whether the minister for health of the day should retain an effective power of veto over this drug, as is currently the case. This is a question of control over and access to a treatment widely available in 22 countries in the world but not available to medical practitioners to prescribe for their female patients in Australia.

Over the last few months the debate on this bill has extended well beyond its remit of the minister’s power and the TGA’s role. The original precept of the bill—that is, the need for a ministerial power of veto over RU486—has sometimes been lost in what has become an extremely emotional and often very personal debate. The debate has also moved to an area of particular concern to me, that of scrutiny and accountability. There has been comparison of the scrutiny or perceived scrutiny of a decision made by an elected member of parliament and minister contrasted with decisions made by the TGA or, as some have suggested, ‘faceless bureaucrats’ within the Department of Health and Ageing.

I want to make a few comments which I trust will be of assistance to the debate on this issue of scrutiny—both public and parliamentary—of the decision as to whether to permit an evaluation, listing or registration of RU486. At present, there is minimal public or parliamentary scrutiny of a decision of a health minister to approve or otherwise the evaluation, listing or registration of RU486 as an abortifacient. Some will say in response, ‘Oh well, the minister is answerable to the public.’ Well, yes, he or she will face a general election every three years, but that is not the level of scrutiny that this issue demands.

The only scrutiny, if you can call it that, is contained under section 23AA of the Therapeutic Goods Act 1989, whereby the minister is required to notify the parliament of a decision to approve an application for the evaluation, registration or listing of RU486 by the TGA within five sitting days of that approval. The minister is not required to seek advice and is not required to follow any protocol when making a decision regarding an application for listing or registration of RU486. The minister is not required to give any reasons when making a decision regarding the evaluation, listing or registration of RU486. The minister’s decision is not disallowable by the parliament. The minister’s decisions cannot be challenged in the Administrative Appeals Tribunal. Theoretically, a minister’s decision may be challenged under the Administrative Decisions (Judicial Review) Act, the only way a statement of reasons can be acquired compulsorily. However, this would not provide for a review on the merits of that decision. Rather, it would make available a review only on legal grounds, including error of law and irrelevant considerations. So let us be clear: under the current provisions of the Therapeutic Goods Act there is no requirement for the minister to give reasons and no opportunity for review on the merits of the minister’s decision.

By contrast, the Therapeutic Goods Administration is subject to considerable public and parliamentary scrutiny in the exercise of its functions and is accountable for them. The TGA does not itself carry out the assessment of prescription drugs. It is not accurate to say that these tasks are performed by bureaucrats in the Department of Health and Ageing. The task of assessing prescription drugs is in fact carried out by the Australian Drug Evaluation Committee, which was established in 1963 and has the role of providing independent, scientific advice to the federal government on new drugs. This body consists of six or seven core members of experts and up to 20 associate members. Of the core members, at least three must be eminent medical practitioners with at least two specialists in clinical medicine and one must be a pharmacologist or hold a degree in science, specialising in pharmaceutical science. The associate members must include at least one pharmaceutical chemist with recent manufacturing experience in therapeutic goods, at least one toxicologist and a medical practitioner in general practice. All of them are appointed by the Minister for Health and Ageing. They are health experts who are working in medical and clinical settings every day.

The Australian Drug Evaluation Committee’s recommendations for approval of new drugs or changes to registration of existing drugs are publicly available on their website and their recommendations are published in the Gazette. The committee, ADEC, makes its recommendations to the delegate of the Secretary to the Department of Health and Ageing, who is in fact a senior medical officer of the TGA. The delegate’s decision ultimately to approve or not to approve may be challenged in the Administrative Appeals Tribunal, and this provides the option of a review on the merits. The AAT stands in the position of the original decision maker and determines if the decision was in fact the right one. If the TGA determines to approve a drug, it is then listed on the Australian Register of Therapeutic Goods, a publicly available document.

Any drug approved by the TGA then goes through the further process of an evaluation by the National Drugs and Poisons Schedule Committee, which comprises state and territory government members and other persons appointed by the Minister for Health and Ageing—such as technical experts and representatives of various sectional interests, such as the professional colleges. This body makes determinations, decisions and recommendations pertaining to a drug’s retail supply and can restrict its use. Further, reports of serious reactions, for example, are forwarded to the Adverse Drug Reactions Advisory Committee for further assessment. This committee is composed of independent medical experts who have expertise in areas of importance to the evaluation of a medicine’s safety. This committee can make any of several decisions for a report, including that there be publication of the reaction to raise awareness, through to recommending the restriction or even the removal of the drug from the market.

Finally, the TGA is accountable to the parliament, first, through the provision of annual reports provided to government. The TGA is considered to be part of the Department of Health and Ageing for this purpose. Secondly, the TGA appears before the Senate estimates committee and is regularly interrogated by senators on specific drug evaluations and approvals. Parliament can hold inquiries into issues of public concern, including into the functions of the TGA, if it so wishes. The function or act of delegation under the Therapeutic Goods Act can be changed by legislation. It is subject to the scrutiny of our National Audit Office.

The situation which our current laws have produced is perverse. Under the current laws, RU486 is currently being trialled and used in Australia for other indications under the clinical trials and the special access schemes provided for in the Therapeutic Goods Act 1989. In the Senate Community Affairs Committee inquiry we heard evidence that RU486 is currently used for the purposes of emergency contraception, the control of unacceptable bleeding and in cancer research. Those who obtain approval to test a drug for the purposes of a clinical trial not related to an abortifacient function are not required to seek the approval of the Minister for Health and Ageing. By contrast, a range of drugs listed as restricted goods for the purposes of the Customs (Prohibited Imports) Regulations 1956 which can have an abortifacient effect are currently in use, including as abortifacients.

Misoprostol, a prostaglandin, is approved in this country to be used in the treatment of gastric or duodenal ulcers. However, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists has recognised the use of misoprostol as an aid to medical abortions. The drug is used under controlled circumstances in teaching hospitals where there are protocols and ethics committees to ensure it is used in appropriate and safe circumstances.

The medical profession, led by experts with solid clinical and pharmacological expertise and experience, has had to find ways of providing women—for example, those who cannot tolerate anaesthetics—with a medically essential choice to overcome the perverse situation which the 1996 amendments to the Therapeutics Goods Act created. I ask my colleagues: if you or your wife or partner or sister or daughter were facing a termination, for whatever reason, would you want her to have access to what health experts may consider the best, most appropriate medical treatment as prescribed by her doctor for her particular circumstances?

Under our parliamentary system ministers come and ministers go. It is time to recognise the value of the system this parliament put in place in 1989. It is a system of expert evaluation of proposed prescription drugs subject to significant public and parliament scrutiny: the expert Drug Evaluation Committee, whose findings are public; the decision of the TGA, whose findings are public; the national drugs body, comprising state and territory representatives, whose findings are public; and the Adverse Drug Reaction Advisory Committee, whose findings are public. At each level it is subject to scrutiny and, overall, subject to administrative appeals review. The evaluation of all drugs through this rigorous process is a system worthy of our trust and our support. For these reasons, I support this bill.

Simon Crean (Hotham, Australian Labor Party, Shadow Minister for Regional Development) Share this | Link to this | Hansard source

I, like the Minister for Education, Science and Training, support the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I do not support the amendment that has been put forward. I do acknowledge, like all speakers in this debate, that it is a difficult and an emotional issue. I think all of us as parliamentarians can attest to that, because all of us in one way or another have been lobbied in relation to it. I am very conscious that there are people of goodwill on both sides of this parliament who hold very strong views and beliefs that have shaped their decision in relation to how they will vote.

I acknowledge the contribution to this debate in the parliament not just from the Minister for Education, Science and Training, who has just spoken, but from the mover and seconder of the motion to bring this bill before the House for debate, the member for Moore and the member for Lalor. It is also appropriate in the context of the bill that is before us to acknowledge the cross-party promotion of the bill in the Senate by Senators Allison, Moore, Troeth and Nash. The opportunity for both sides of the parliament to get together to present common positions is very welcome whenever it occurs in this place.

Of course we should be examining the issue calmly and objectively when we come to make a decision. I do not think it helps to have slogans and simplistic messages displayed around the parliament. I do recognise the calm and rational way in which most members of this House have spoken so far and the way in which they have contributed to the debate. I also recognise and respect the very personal feelings and experiences that some members and senators have introduced into this debate.

There is a conscience vote associated with this bill. That, in itself, is a rare occurrence in this chamber. It does bring with it a different tone. It brings with it a lot of soul-searching, a lot of personal experiences—people grappling with competing arguments. In many cases this has been a difficult and agonising process of personal reflection and consultation with friends and family, with organisations, whether they are in our constituency or of a national nature, as well as with specialists and medical experts.

Like all other members in both chambers, I have thought long and hard about this issue. I have been reading as much as I can about the medical, moral and ethical aspects of the matter. I am also very grateful for the advice and comments I have received from many of my constituents on the matter. I have received a large number of representations from the people of Hotham in relation to this issue. I respect their views. I always have and I always will. Interestingly, they have divided almost equally on each side of this issue.

We are being asked to decide who should decide on the importation of the drug RU486 and other drugs of that class of abortifacients. Should it be the minister for health or the Therapeutic Goods Administration? Ten years ago, when the parliament had to consider this issue, it decided in favour of the minister. Ten years on, medical knowledge has advanced significantly. Speaking to medical experts, as I have, different treatments and new drugs have clearly become available and are continuing to be developed. I have the very strong view that it should be the medical experts and not the minister for health who should determine whether or not they are appropriate for use in particular circumstances.

This is not a debate about abortion or about the personality, character and beliefs of the current minister for health. Nevertheless, it is a debate that raises difficult moral and medical issues. Because of that, all parties have decided that there should be a conscience vote in relation to it. A conscience vote means just that—that members should be permitted to vote according to their consciences. I have said before that I know views differ on this side of the House, but I respect the honesty and the depth of feeling that are behind those views. Labor’s policy as expressed in our platform does not specifically deal with RU486, but it does say that Labor will:

... support the rights of women to determine their own reproductive lives, particularly the right to choose appropriate fertility control and abortion.

I agree with that position. I think that matters of reproductive health and of abortion should be matters for a woman and her doctor. As to whether or not a particular drug should be made available, that should be a matter for the Therapeutic Goods Administration, the statutory authority established by this parliament which determines access to all kinds of other drugs, including drugs that may well be dangerous or addictive if misused. It should not be a matter for a politician to veto—one person with his or her own views who may or may not seek appropriate expert advice. Here we are talking of a conscience vote determining the deliberation of this bill but, the way things stand, one person’s conscience can veto whether or not tests can be conducted.

Since 1996 we have had an effective veto on RU486. The requirement for ministerial approval has been such a disincentive that since 1996 RU486 has not been imported for research or clinical use. Labor supported the amendment in 1996 that required ministerial approval for the importation of RU486. We did so then in recognition of the sensitive nature of the issue and the undoubted community concern about it. We also supported the amendment in 1996 because at the time there were concerns about the long-term health effects of RU486. There is no doubt that community concern still exists about it today, but we now have far greater knowledge about RU486. Ten years on, there have been huge leaps in the understanding of it. In 1996 we did not intend the amendment to constitute a ban on RU486, but that is what it has become.

My fundamental position on the specific question of the availability of RU486 is that the decision should be made by the expert body, the Therapeutic Goods Administration. That is why I support this bill. We entrust the TGA with decisions on other drugs, drugs that can be dangerous or addictive if misused. We should entrust it also with this class of drugs. I do not accept the argument that the TGA is somehow unaccountable and the minister is more accountable and should make the decision. It was interesting to hear the minister for education in her contribution point to all of the bodies that have to be associated and the way they have to be publicly accountable.

If it were the case that the minister must always override, why have expert bodies? Why have those expert bodies make decisions on anything? Why not just leave it to the minister? Clearly, that is an absurd proposition. There is always the need to delegate responsibility to expert committees where matters of a technical nature and matters of health and safety are clearly concerned. As to the pressure that is being put on people to vote in a certain way, possibly by pressure groups or by the views of the Prime Minister or the minister for health or by the result of the vote in the Senate, I am confident that the members of this House are sufficiently independent and honest to make their own decisions.

This is not a no-confidence vote in the minister or in the parliament—that is a ridiculous proposition. It is a vote of confidence that members and senators can weigh up the evidence, examine their own consciences and come to a decision which they can justify to their constituents and to themselves. This is not a debate about abortion either. It is not a debate about whether or not abortion should be legal. The courts have decided that in certain circumstances it is legal. Given that it is legal in certain circumstances, the medical advice must be based on providing the best possible solution. That must be a decision for the experts. Currently the experts cannot prescribe the drug because of a ministerial veto. This bill is about ending that veto and leaving the consideration of a woman’s health to medical experts.

What we are debating is who should determine whether this drug should be made available. This is a conscience vote, and each member will be voting according to their conscience. It is ironic that, if this bill is not passed, the matter will continue to be determined by the conscience of one person: the Minister for Health and Ageing. I believe that it should be a decision for medical experts and not for the minister for health. That is why I support the bill.

Danna Vale (Hughes, Liberal Party) Share this | Link to this | Hansard source

I begin my remarks on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 by acknowledging the depth of conviction thoughtfully held by my colleagues on both sides of the House on this issue. I have listened to many of their speeches, and I am aware that their points of view are very genuinely held. However, I have heard nothing that can persuade me from voting against this bill.

In the time available to me, I will set out some of the major issues that are raised in this Senate amendment bill. Firstly, it must be pointed out that this bill is not about the accessibility of abortion for Australian women. Surgical abortion is available in every Australian state and territory and has been for many years.

Secondly, the subject matter of this debate is an abortifacient called RU486, which, if this bill succeeds, will be approved in the normal administrative processes of the Therapeutic Goods Administration, as are all other pharmaceuticals before they are dispensed in Australia. It is the role of the TGA to evaluate and approve each new drug for its safety, efficacy and quality. However, the TGA can only evaluate drugs on the basis of physical efficacy, not on the basis of any psychological or emotional effect.

At the present time, RU486 is subject to section 23AA of the act and, because it is an aborting agent, it is classified as a ‘restricted good’, which means that the TGA can evaluate RU486 only after the approval of the Minister for Health and Ageing. This amendment will mean that the minister’s approval is no longer required. RU486 will be assessed by the TGA in the normal course of its administrative activities, as if it were a normal therapeutic drug.

Thirdly, as an aborting agent, RU486 can end a developing human life. It has been suggested by the proponents of this Senate amendment bill that the bill is strictly about process and only process. However, precisely because RU486 is an abortifacient and can end a developing human life, it also raises issues of ethical, moral, social and political concerns and issues of health and safety for the mother.

Fourthly, this matter is about the accountability of the process. It is about ministerial responsibility and accountability. I cannot imagine any other circumstance of great ethical, moral, social, and political import that calls upon a minister to exercise his or her authority in the way legislation such as this does. Such concerns are not able to be appropriately considered by an administrative body. That is not the function of the Therapeutic Goods Administration. No matter how worthy its members may be, they are not accountable to the people of Australia. That is not their responsibility. As I have earlier pointed out, the role of the TGA is an administrative one. They are bureaucrats. In our system of government, it is the minister who, standing between the people and the bureaucracy, carries the responsibility for policy. It is the minister who, as an elected representative, is responsible and accountable to the people of Australia.

In 1996 when the Therapeutic Goods Amendment Bill was passed, it was agreed by both sides of the House that drugs such as RU486 should not be allowed into Australia without the approval of the health minister. In the debate on the bill, Senator Harradine pointed out:

People on both sides of the abortion debate agree that the importation, trials, registration and marketing of such agents ... should not be left in the hands of bureaucrats and science technologists. There should be ministerial responsibility ...

I wholeheartedly agreed with the Senator’s statement then, and I do now. I see no reason to change it.

Further, I cannot help wondering whether, if the present minister was of a mind to approve the referral of RU486 to the TGA, we would be debating this legislation today at all. While the present Minister for Health and Ageing is not of a mind to give his approval to the TGA to assess this abortifacient, a future minister may well be inclined to do so. Such a decision will be a matter for that minister, and he or she will be accountable for that decision to the people of Australia.

Fifthly, another very important aspect of this debate is the issue of the health and safety of the mother. I understand that it was noted on ABC 666 last Wednesday morning that the UK Royal College of Obstetricians and Gynaecologists has highlighted that it is difficult to come to a definitive conclusion on RU486, simply because the scientific evidence is inconclusive. Moreover, what science has been conducted regarding RU486 is considered by the college to be very problematic or ‘grey’ in nature, given its ideological slant either way. I also understand that science has not yet discredited the argument that RU486 contributes to breast cancer.

RU486 is a highly controversial agent, and we in this place must also be concerned that there is documented evidence in the United States and in Canada of women dying after the use of RU486. Moreover, I understand that, even after using RU486 to induce an abortion, a number of women haemorrhage and still require a surgical abortion. I am informed that the Italian government has also placed a limited ban on RU486 because of these same concerns, in that one in 20 women experienced partial abortions and excessive bleeding. I understand that the warning label on RU486 clearly indicates that some women may need a surgical procedure afterwards, either to complete the termination or to address excessive bleeding. The proponents of RU486 clearly warn that this agent should only be administered under strict medical supervision.

In this regard, I find it difficult to understand the argument put by the proponents of the bill that this agent should be available to women in rural areas who, because of a shortage of doctors in their areas, are unable to access surgical abortions. This situation raises a number of serious ethical questions about how we can best provide women in rural areas with the best possible health care, along with their right of personal choice in such matters. We certainly cannot leave women to the effects of a drug whose manufacturers recommend that it be administered ‘only under strict medical supervision’, when those women live in rural areas where there is no medical supervision available.

The proponents of the Senate amendment claim this bill is not about abortion, but the many speeches that I have read all mention abortion to some degree—and, in some cases, to a very personal degree. In dealing with any legislation before this House, each and every one of us has to be mindful of its consequences within the wider community. With this particular piece of legislation, that is especially so.

Abortion is available in Australia and, while women may exercise their choice, I would also like to see the government give women more choices. Every unborn child has the potential to make a significant and wonderful contribution to our great nation. I believe as a government we should actively invest in that potential and provide Australian mothers with more practical support, more financial assistance, more accommodation options, more education and training for themselves and more appropriate provision of child care, so that they can have more choice with respect to keeping their children rather than more choice with respect to how to abort them. I note the amendments on the table which give parliamentary scrutiny of the legislation to the House. I support the member for Lindsay’s amendment, which maintains ministerial responsibility.

I now wish to refer to certain statements I have made in recent days in considering RU486—and to some media reports on my comments, especially those that accuse me of being a racist. I am not a racist, and I never have been. Most of the colleagues on both sides of the House with whom I have had the privilege of working for these last 10 years know that I am not a racist and never have been. I utterly and totally reject such accusations as those that have come from some sections of the media. Regrettably, some members of our fourth estate have gone over the top in their reporting of this issue, and I believe they are striving to find racism where there is none. However, I need to clarify the point that I was trying to make in a media interview the other day when, in saying that Australians are aborting themselves almost out of existence, I made reference to Muslim Australians. Muslim Australians place a high value on their children and, like many other faith communities, see that the core issue is the right to life of the unborn child; and, indeed, that sexual conduct carries with it a responsibility. I also note that the Muslim community of Australia continues to oppose abortion. I strongly share this belief.

The reported estimate of abortions in Australia, somewhere between 80,000 and 100,000, has to be alarming to each and every thinking Australian. Australia today, for most of us, is a wonderful, comfortable, modern, convenient, instant, high-tech indulgent society. We are constantly told that if we want it we can have it. For most of us, we have such control over our lives. Importantly, since the sixties we have also had control over our own fertility in a way that no generation before us in all of human history has. This has given us unprecedented power over who we are and what we want to become. It has also given us a terrible control over the next generation. We appear to exercise this control without any thought as to the cost—and nothing is free. The cost is ultimately paid by all of us in the kind of society that we have become today.

The core issue of this debate is the right to life of the unborn human being. Let us make no mistake about it. We can call it ‘process’, we can refer to ministerial accountability, but ultimately the core issue of this debate is the right to life of the unborn human being. This debate is about the sanctity of life itself. We were made by love, we were made to love and we were made to be loved. We were born to recreate. In our history, the values of religion and faith communities were centred on the principle of the sanctity of life. Today, we do not value life simply because it is a life, and I believe the loss of this core value in the wider Australian community, evidenced by the large abortion rate—albeit an educated estimate—impacts on so many other aspects of Australian society today.

Once upon a time in our history, children were seen as producers and wealth creators for their families and the future sustenance of their village communities. Children were valued. In our self-indulgent, convenient, modern, easy contemporary Australian lifestyle, children are now seen in some sections as consumers and polluters and just plain hard work. Of course, there are many children who are treasured by their families, but the increasing numbers of children across Australia who are neglected and abused must be a concern to us all.

We can also point to the decline in civil society. Graciousness and good manners are no longer seen as an attribute.  We often hear complaints of lack of respect generally, of children who are uncontrollable, of concerns about an increasing number of children who are, for want of a better word, ‘feral’. I am mindful of the two 14-year-old girls in Sydney who are currently charged with murder. Such children are products of the society we have become—and collectively, as a society, we have failed these two girls.

We also see signs of the weakening of the fabric of our society in the way in which we treat our mentally ill and our disabled citizens—or anyone else, for that matter, who is not considered to be perfect. In other words, because we have such control over our fertility, the cost has been to lose respect and awe for human life itself. Hence, human beings in contemporary Australia have become another commodity. Human beings are capable of exceptional rational thought and judgment and of full and rampant emotions. Human beings can show laughter and sadness and are capable of awesome heroism and defiant bravery. Human beings are capable of exquisite poetical expression, groundbreaking innovation and invention. Human beings have an unbounded potential to contribute to the welfare of their fellows and are the epitome of God’s creation. But contemporary Australia, based on those large abortion numbers, has lost sight of the true meaning of a life—a human life, valued by the rest of its community simply because it is a life.

We can see the impact of this loss in the society we have become. I use this opportunity to call for Australia to return to the core values of our forebears, who, unafraid of the hard road and the harsher life, made this country, this Australia, the great nation that it has become. Then, together with all of the various faith communities in our land, we can face our future in understanding and mutual respect. I do hope that this clarifies in some way what I was trying to say in a very clumsy way in a live interview the other day, for I deeply regret any offence that might have been taken by members of the Australian Muslim community.

Stephen Smith (Perth, Australian Labor Party, Shadow Minister for Industry, Infrastructure and Industrial Relations) Share this | Link to this | Hansard source

I support the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. For reasons which I will outline, I do not support the amendments. It has been suggested by some that this bill, this debate, is not about abortion. I do not agree; I think it is about abortion. It clearly is. I do not think we should pretend otherwise, nor should we shy away from that. So far as abortion is concerned, my starting point is that abortion is a matter of conscience for the individual concerned. The choice to have or not have an abortion is a matter of conscience for the individual woman in consultation with her medical advisers. This is not a view I have come to lightly or quickly, but over the years of my adulthood that is the view I have come to hold. I also strongly believe that as a matter of conscience we should not seek to impose any one view on anyone else. We should not, and I do not, criticise others for their views or their choices in this matter.

In Australia as a nation-state we have over time addressed the abortion issue. And we have come as a nation-state to a number of conclusions. First and foremost, it is a matter of conscience. This itself is reflected in our approach to this parliamentary debate both here and in the Senate. Second, abortion is legally available under state and territory law as a medical procedure under certain conditions. Under Australian state and territory law abortion is a legally available medical procedure for women to choose. Third, the Commonwealth—the Commonwealth generically, as the Prime Minister says these days; namely, the parliament, the government, the Prime Minister and the minister for health—generically accepts this approach and position. That is done through Commonwealth funding and financial support of abortion as a legally available medical procedure, whether that is through Commonwealth funding for state public hospitals, through Commonwealth financial support for private hospitals or through Medicare through items under the Medicare Benefits Schedule or the Medicare safety net. That has been the case for some considerable time.

The threshold decision on abortion so far as the Commonwealth is concerned and so far as this parliament is concerned was made nearly 30 years ago. That occurred in the Lusher debate of 1979, where this House resolved:

... this House is of the opinion that the Commonwealth Government should not pay any medical benefits for or in relation to the termination of pregnancy unless the procedure is performed in accordance with the law of a State or Territory.

No Commonwealth government has sought to disturb that approach since then. It is open to members, senators, ministers or prime ministers who conscientiously disagree with that approach to seek to disturb or change that position and approach. But the key point is this: this parliament long ago made a threshold decision that abortions are legally available medical procedures for women to choose under the laws of the states and territories, and the Commonwealth parliament and the Commonwealth government accept that and fund that.

I make that point because I have seen the argument that to agree with this bill is to abrogate responsibility as parliamentarians and to leave the question of abortion to faceless bureaucrats. Mind you, these so-called faceless bureaucrats are the same people—scientists, medical practitioners, clinicians, specialists, experts—to whom we leave the decision making to judge the safety and appropriateness of medical procedures and pharmaceuticals. We leave it to them on the public policy basis that these decisions are best made by experts reliant upon the best scientific and medical advice, not by ministers, members or senators. That is why this parliament established the Therapeutic Goods Administration. As a matter of public policy, the parliament believes the TGA is best placed to make those decisions.

I make this point about threshold decisions and the legislative framework because I believe there is an appropriate analogy here. The last occasion this House had a conscience vote and a conscience debate was in respect of stem cells. We said that was a matter of conscience, and as a parliament we made a threshold decision. We determined the parameters of the use of stem cells for research and we expressly prohibited a range of approaches. Having determined the parameters, members of this parliament are not now in every laboratory or every research facility making day-to-day clinical or research decisions. Those day-to-day clinical and research decisions are made on the basis of science in accordance with the legislative framework and the threshold decision this parliament has made.

The same is, in my opinion, true of this debate. Having accepted the parameters and the threshold about abortion, the issue of this bill is whether a particular medical approach, a pharmaceutical, should be available in addition to surgical procedures for abortions under state and territory laws. The judgment has to be made whether that is a safe and appropriate medical procedure and approach. I believe that decision is best left to clinical, scientific, medical expert advice. That is the best way to judge the risk and the appropriateness of its use. As I said earlier, that is why as a parliament we established the Therapeutic Goods Administration.

I believe things are qualitatively different now than when this parliament made its previous decision in 1996. The TGA is now in a position to review international experience of over a decade. RU486 has been used in the United States of America, the United Kingdom, New Zealand, Israel and France for over a decade. The TGA can assess the clinical and medical experience from those countries. The TGA, in my view, is best placed to judge the risks, not a member or minister of this parliament. I have seen no argument which would persuade me that RU486 should be treated differently—should have a separate or different approach—to the 50,000 or so items which the TGA has previously dealt with. I do not believe that this is an abrogation of responsibility. I believe that it is a sensible public policy judgment that the TGA is best placed to make that assessment. I oppose the amendments because they would simply see this same debate brought back here on a case-by-case basis.

If the Prime Minister, the Minister for Health and Ageing or any other member or senator in this parliament as a matter of conscience disagrees with the threshold approach that the Commonwealth has taken or with the legislative framework that exists, it is open to them as a matter of conscience to do something about it in moving to take away Commonwealth financial and funding support for the current framework. I do not believe that will occur. I do not believe that the Prime Minister or the Minister for Health and Ageing would do that—and that is because, I believe, a clear majority of Australians believe that the current framework is appropriate, based as it is on regarding it as a matter for an individual concerned, on the basis of medical advice received from a medical practitioner.

I have seen some criticism that to adopt such an attitude is to promote abortions. I find the idea of one abortion profoundly distressing—let alone how profoundly distressing it must be for a woman who has to choose to have an abortion or not have an abortion, whether the reason for the abortion is the health and safety of the woman concerned, the fact that the sex causing the pregnancy had not been consented to by the woman concerned or that the pregnancy was unplanned.

It was said earlier that slogans in this area are not useful, and I think that is right. But my attention has been drawn to the comment of a former President of the United States, who said that he wanted abortions to be safe, legal and rare. If you want abortions to be rare, in my view, you have to be up front about sex education in schools and in the wider community and up front about contraceptives. If you want to ensure that abortions are minimised or rare, you have to be up front about prevention.

It has been suggested also that this is a debate or an issue where only women can have a view; that men are not entitled to have a view. I profoundly disagree with that sentiment. We are all equal members of our society. But, just as equally, I strongly agree with the view that no woman or man should seek to impose her or his view on an individual woman who is making a choice about whether to have an abortion or not.

As part of this debate, some have suggested that the Minister for Health and Ageing has been attacked for his Catholicism. I do not attack or criticise the Minister for Health and Ageing or anyone else for being a Catholic or for not being a Catholic—for holding religious views or not holding religious views. It has to be said, though, of the Minister for Health and Ageing that, as a member of public office, he does wear his Catholicism on his sleeve. This will see some supporting him and some criticising him. In my experience, the vast bulk of practising Catholics, whether they are in this place, in public life or in the wider community, do not wear their Catholicism on their sleeve. They practise their Catholicism quietly, conscientiously and reverently.

If I were to utter in public a criticism of the Minister for Health and Ageing, it would be this: advertently or inadvertently, he seems to have made this issue and abortion the sole test of Catholicism. I do not believe that that is right. Members of the Catholic community that I speak to have diverse views on abortions; they have diverse views on RU486. Some—or many or the majority; I do not know, and I do not seek to quantify it—devout practising Catholics do not follow the church’s teachings and rulings on these matters. But I do not believe that makes them any less of a Catholic. I do not believe that this issue is the sole or single test of Catholicism or faith.

I have, for example, in my own electorate in Perth been subject to the views of a woman over 70 years of age who is a devout Catholic, who tells me advisedly and assuredly that, when it comes to abortions, ‘Stephen, it has nothing to do with the Pope; it has nothing to do with you as a member of parliament. It is something for the woman concerned in consultation with her own doctor.’ So there are diverse views, as far as the Catholic community is concerned.

I might just draw from an example that I found in the West Australian in February 1998, where a Catholic woman who had had an abortion regrettably had that matter made public. The woman became pregnant when her husband’s vasectomy reversed itself. The woman, who was named as ‘Sue’—although that is not her real name—was Catholic, had three children and also had had three stillborn babies. She is quoted in the West Australian as saying:

We are people—

referring to herself and her husband—

who value human life. We approached this decision with a great deal of difficulty. I believe my God is a forgiving God. My God will forgive me for what I have done.

There is the view of one devout Catholic who had an abortion. It was a profoundly difficult decision but, if in the end she had done the wrong thing, her God was a forgiving God and her God would forgive her.

I have not seen an argument that would persuade me of anything other than that the correct public policy position in this area is that the question of the use and availability of RU486 should be left, in the usual manner, to the scientific, medical and expert advice of the Therapeutic Goods Administration and that, if the Therapeutic Goods Administration authorises its general availability, medical practitioners in individual cases should make decisions about its use in particular circumstances, depending on their expert medical advice. I commend the bill to the House.

Warren Entsch (Leichhardt, Liberal Party) Share this | Link to this | Hansard source

I welcome the opportunity to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I will keep my words reasonably brief to provide a chance to as many members as possible to speak. In commencing my remarks, I would say that the amount of correspondence and communication I have received on this issue and the broad range of opinions that have been put forward in relation to this debate have been amazing. I am also amazed at the number of experts there are, because the overwhelming majority of comments that have come through to me are from individuals professing to have quite a comprehensive understanding of the properties of this particular drug, when advocating or opposing its application.

As the previous speaker rightfully said, the debate has certainly focused on the issue of abortion and whether or not we should accept abortion in this country. But he is also right in saying that in fact legal abortions have been accepted in this country for some 30-odd years now and have been funded both by state governments and by Australian governments through our Medicare system. Of course the policy view is that the support is for safe and legitimate medical procedures.

I think the argument that accepting the TGA’s advice on this particular drug is going to lead to a massive increase in the number of terminations in this country is false. While personally I have an issue with abortion—it is not something I would advocate in my own circumstances or for family or for friends—I accept that at times there are circumstances where termination is considered and where it is sometimes necessary in saving a life. In my view, it is a decision that is never taken lightly. Some suggest that it is a convenient means of birth control. I certainly reject that argument. For those I know who have had to go down this road, the decision, once taken and once the procedure has occurred, is with them for the rest of their lives. So it is not something that is taken lightly. But, in relation to RU486, it is at the point after the decision is made between an individual and her doctor to terminate a pregnancy, for whatever reason, that they start to consider what options are available in relation to that termination.

While the Therapeutic Goods Authority is an administrative authority and while there has been some argument that it is a faceless bureaucracy that is not qualified to make a decision in relation to whether or not this drug is suitable to be used by the Australian public, I reject that in so much as it is but one layer of an assessment process that examines all drugs. We have the Australian Drug Evaluation Committee, which is in fact appointed by the minister. That committee is made up of a team of highly qualified experts, and their qualifications cover all areas of medicine. Their job is to provide independent scientific advice on any new drugs, within the policy framework of government. They look at the quality, risk benefit, effectiveness and access within a reasonable time frame of any drugs referred to them for evaluation and at medical and scientific evaluations of applications for registration of prescription drugs, new chemical entities, new forms of previously registered drugs and therapeutic variations to registered drugs. It is their responsibility, as experts, to evaluate these drugs and make recommendations to the minister. Quite frankly, once these experts have made these decisions and once they have given their recommendations, I do not believe there is anybody in this place who would be qualified to argue whether or not that advice is accurate.

We rely on this process for every other single drug that we have available to Australians in this country, and it is my view that this expert panel should also be used to make decisions about RU486. I recall correspondence suggesting that there have been nine deaths around the world attributed to the use of RU486. Those who argue very strongly on that basis do not provide statistics in relation to the number of deaths from other procedures for termination, nor do they provide any information in relation to the number of deaths from childbirth itself. I cannot take their point of view into consideration if it is argued without providing the rest of the information.

I have not made this decision lightly. Like many of my colleagues, I have had a huge amount of mail on this issue—probably equally balanced between those for and those against—and I have had to consider my own personal view. At one stage there was a suggestion that if this particular drug were to be provided in remote Aboriginal communities—in my electorate, for example—it would cause serious problems for women in those communities.

But the advice I have received about the application of this drug is that, if the decision is made to use it as a method of termination, it is not something that can be picked up on prescription, which is something that a lot of people believe. It has to be collected and administered by the doctor and, of course, ongoing medical support has to go with it. I see it as another option available to women who are facing a very difficult decision in their lives—one that many may choose not to take, but the option is there if they choose to have it available.

It is not available now; it still has to be evaluated. We may find, given the myriad information that is being provided to me, that the experts who are involved in the evaluation process—and I am sure that that information and more will be available to them—may decide that the drug is not suitable, and the debate may well be for nought. But I believe that it is critical that we maintain the integrity of the evaluation system that has served us so well for so many years, and I believe that a decision on which drugs are suitable for Australians should be taken by the expert committee. So I will be supporting the bill, and I will not be supporting the amendments that are being put up.

Peter Andren (Calare, Independent) Share this | Link to this | Hansard source

Let me say at the outset that I will abstain from voting on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I know that that may be regarded as a cop-out and as disfranchising my electorate, but I hope that I can explain my dilemma. Let me also state that I support pregnancy termination for medical purposes. I also recognise that abortion is more and more available, not just for medical reasons but as a form of birth control. I am not happy with that trend but acknowledge that it is a fact of life beyond the control of parliament—unless it were to outlaw abortion and return us to the time when abortion was hidden and the outcomes often terribly damaging.

So where does this leave the argument on my position? Logic suggests that the Therapeutic Goods Administration is the only body capable of judging the efficacy of a drug entering the Australian market. It should not be the role of one minister, cabinet or parliament as a whole to impose political judgment on such approvals, for it would be a judgment with little or no medical expertise. The judgment of a drug’s production, side effects, efficacy and administration should rest with a professional organisation such as the TGA but with a rider—as we move into assessing a drug that has so many ethical, as well as medical and scientific, questions about it, surely there needs to be an ethicist on board the TGA process.

I am not convinced that the TGA has the necessary powers to monitor this particular drug, or set of drugs, as this process we are examining really entails, for this involves mifepristone and a prostaglandin taken in tandem to achieve a termination. I do not disagree that where a surgical or medical option is available a woman should have a choice. But it is not the choice but the supervision of the choice that disturbs me. My concern surrounds the protocols for administration and follow-up in the use of these drugs. I am not convinced in my examination of the TGA’s responsibilities that sufficient protocols are currently in place to ensure that doctors prescribing these drugs would be involved sufficiently in the entire process, especially in country areas. I am not satisfied that key bodies such as the AMA have even considered the need for much tighter protocols in the case of these drugs.

What concerns me is that vulnerable women, many of them very young, will, if not required to self-administer these drugs, be alone while the termination process is occurring. In response to concerns about some outcomes from the use of the drugs, a US Food and Drug Administration alert of July 2005 states:

Patients should contact a healthcare professional right away if they have taken these medicines and develop stomach pain or discomfort, or have weakness , nausea, vomiting, or diarrhea with or without fever, more than 24 hours after taking misoprostol. These symptoms, even without a fever, may indicate sepsis. Make sure your healthcare practitioner knows that you are undergoing a medical abortion.

To my mind, the American situation leaves the onus very much on the patient, and therein lies some of my concerns about the protocols that may in future be in place here.

If I were convinced that these drugs were administered within a clinic and the woman supervised and cared for in a clinic as with a surgical abortion, I would have no problems. But this drug is being promoted as an answer to isolation, for country women to be able to achieve terminations without the expensive, time-consuming trip to a city or major centre. It may save time on travel to an urban clinic, but I doubt that it will offer emotional security anywhere near as much as a clinical procedure, where at least there is medical and, one would hope, psychological support.

I am conscious of the written advice to the Minister for Health and Ageing from Chief Medical Officer Professor John Horvath that the use of RU486 for abortion ‘carries a significantly higher risk’ than surgical abortion of later adverse events and that the use of medical abortion by GPs in situations where there was not ‘an established relationship with an obstetric service that could deal with emergency complications outside normal clinic hours would substantially increase the risks to women undergoing termination’. The AMA executive, councillor and obstetrician, Dr Andrew Resce, responded to the CMO’s advice by stating that women would only be able to gain access to medical abortion ‘under the supervision and advice of a doctor who would be responsible for managing the entire termination process’.

Therein lies my concern. How is this possible in all circumstances, especially in remote and not so remote rural communities—in Indigenous communities as close to Bathurst, say, as Hill End, an hour and 15 minutes away over a lot of winding gravel road? I do not believe the supervision, the obstetric backup or the management processes are in place. Equally, I do not believe the minister of the day or parliament should be the judge on this. Nor do I believe that women should, as some have suggested, be the judge and that men should butt out. A pregnancy also involves a male.

There is much pressure on many women to take the abortion route, and we must ensure we have in place absolutely every support necessary to enable a woman to also exercise her own choice to continue a pregnancy. For many young people—indeed, for many women in general in our society—the prospect of an unexpected pregnancy is accompanied by financial panic, a lack of child-care options or perhaps pressure from partners to abandon the relationship. The reality is an unexpected pregnancy has financial consequences long before the emotional and medical issues are considered.

The most recent Bureau of Statistics child-care survey shows only one in five children from low-income families in Sydney can access long day care or preschool, and in a society where the extended family is more and more becoming a truncated and disjointed one almost 80 per cent of these families do not have grandparent care. The child-care situation is even more critical in rural areas, including my electorate. Barnardos Australia says there are simply not enough child-care places and that they are too expensive anyway, even with the maximum child-care benefit. The AMA, in its submission to the Senate inquiry, at least in part recognising this crisis suggested child-care costs should be claimed as an expense and paid pre tax. The AMA seems to ignore those many pregnant women who may be below the tax-free threshold. They do not need tax breaks; they just need a break. These are the vulnerable for whom every emotional, financial and medical support must be available in the event of a termination, if indeed it is recommended.

I have carefully studied the Senate Community Affairs Legislation Committee report on the bill. At page 14 it states:

The medical groups emphasised the need for legal terminations to be performed safely and to the highest possible standard to ensure that women who choose this option do not suffer unnecessary harm.

Can those medical groups guarantee that medical abortions offer as many safeguards as clinical termination, especially for women in rural and remote areas? The TGA risk management approach states:

… the healthcare provider (the medical practitioner) evaluates risks for the individual patient …

That may be so, but I ask: how can the risks be assessed on a woman suffering heavy bleeding, monitoring her condition perhaps alone or with inexpert company in the 12 days or so between the taking of the second of the two drugs and the return visit? A phone call to the doctor is an option, but will the GP always be available in a country area? Do we rely on mobile phones? The TGA risk management approach also says it encourages practitioners to report adverse events and that it communicates through peak bodies and forums. I do not think these procedures are sufficient in the case of what could be a largely self-managed medical procedure of such monumental emotional and physical impact.

In New Zealand there is the Abortion Supervisory Committee which oversees the operation of protocols for early medical abortion procedures. That would seem to be the very least we need here. Contrary to statements in the Senate report, I do not have confidence that under the TGA’s current drug oversight women will have the level of medical supervision currently required in a surgical termination. In evidence to the Senate inquiry, Dr Renate Klein, who does not oppose abortion but does oppose this medical option, proposed the establishment of a committee of informed community members, including social scientists, doctors, pharmacists and, importantly, ethicists, to conduct its own investigation into the availability of RU486 and its accompanying drug regime. This would run in parallel to any TGA study.

In the Senate committee report, the Royal Women’s Hospital noted that ‘gynaecologists are suitably trained to supervise medical abortion’. The RWH also says:

Protocols would be established regarding all of the steps required for medical abortion.

‘Would be established’ is a key phrase. Until they are in place, the TGA cannot effectively supervise and regulate the use of those drugs covered in this bill. The parliament’s job is perhaps to put in place those regulations to give the TGA the power to do its job properly. However, while parliament should be responsible for making laws and regulations to ensure the safe administration of drugs, it is not the parliament’s role through cabinet or disallowance instruments to sit in judgment on the efficacy or risks of a drug, even one that is strictly not therapeutic in intent.

That perhaps approximates the Treasurer’s position—I hope I do not misrepresent him; I listened very carefully to his excellent contribution—but I cannot support the TGA option until I am convinced of its preparedness and ability to supervise this type of drug. The Rural Doctors Association of Australia told the inquiry that rural doctors are ‘keenly aware of their duty’. Of course they are; that is not in dispute. The Rural Doctors Association went on to say:

They know the range of treatment they and their nearest hospital can provide …

The fact is quite a few rural hospitals are not near enough. Some do not have sufficient emergency services to cover unexpected procedures. We have single doctors in single communities covering vast areas, on call at all hours of the night, without the availability when the need is there. That is quite a reality in circumstances like this. A country hospital several hours away is little comfort if something goes wrong.

As the Senate committee report noted, there is a climate of review developing around these drugs. The US Congress has the RU-486 Suspension and Review Act before it. On 30 January the Italian government imposed restrictions requiring every individual request for the use of RU486 to be justified on precise clinical and epidemiological grounds. Trials of the drug have been suspended in Canada despite the country’s liberal abortion laws. Some European countries, according to the Senate committee report, require supervised administration of the drug in a hospital setting and appropriate follow-up. This is closer to the position that I would support, but at this point I cannot see anything in the TGA approach to this that encourages me to think that that will be the outcome.

Indeed, consultant psychiatrists Stephen and Dianne Grocott told the Senate inquiry:

There is a need for independent research into the true psychological consequences of RU486, especially the consequences for women who decline to attend for follow-up.

This, however, is not an argument for continued ministerial control and approval; it is an argument for a proper framework within which our drug advisory and administration process can properly work and guarantee absolutely safe treatment.

The question facing all of us was perhaps summed up by Drs Elvis Seman and David van Gend when they told the inquiry:

The debate on RU486 provides an opportunity for the profession to reaffirm the ethical distinction between medically essential termination of pregnancy and abortion for non-medical reasons.

I ask those who would argue for the sanctity of life in all circumstances to be as passionate on the issue of capital punishment—a dilemma we are faced with at this very moment. It should also be recognised that, among the data available on this issue, medical termination has reduced the death toll from crude, non-clinical abortion in some Third World countries.

I thank all of those people and organisations, particularly my own individual constituents, who have made such strong submissions to me on this issue. I congratulate members for the deep thought they have put into this debate. I reach an impasse: I cannot agree to hand over control of this process at this stage to what I see as inadequate TGA protocols, yet I certainly believe the assessment of all drugs should be in the hands of independent medical and ethics professionals. I certainly do not believe such assessment should be subject to the prevailing position of various governments, cabinets and individual MPs at various times. I reject the amendments, for they also risk political and ill-informed judgments and prejudices based on the whims and vagaries of the parliament of the time on what should be strictly medical and ethical decisions. I hope my position on this bill helps highlight the need to closely examine and review the TGA risk management approach, particularly for the drug regime we are debating here. All my votes are in essence a conscience vote. On this occasion I choose, in good conscience, not to cast one.

Louise Markus (Greenway, Liberal Party) Share this | Link to this | Hansard source

I rise today to make my contribution to the very important issue of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 that is before the chamber today. I acknowledge from the outset that this is a complex and difficult issue that requires careful consideration. There are several issues that we need to consider today, not only the medical implications of the drug RU486 but also the principle that important decisions affecting the community should be made by those people who are directly accountable to the community.

I want to state from the outset that I support the amendment proposed by the member for Lindsay. The amendment strikes a balance between recommendation from the Therapeutic Goods Administration and parliamentary and ministerial accountability. This is a debate of many discrete parts and is about the process of approving abortifacients. People have offered many reasons as to why this drug should be considered differently from those drugs which ordinarily come before the Therapeutic Goods Administration. RU486 is an abortifacient, provoking reaction from all corners of the debate and ought not to be regarded as ‘ordinary’. It was for this reason that in 1996 the drug was moved into the hands of the health minister.

I would like to quickly examine the facts behind RU486. The drug mifepristone is a synthetic steroid that induces medical abortion and is an alternative to surgical termination. It works by blocking the transmission in the body of progesterone, a drug that is crucial to the progression of pregnancy. The uterine lining breaks down, making it impossible for the uterus to hold the foetus. The administration of the drug occurs in two phases. An initial dosage is administered, followed two days later by a course of prostaglandin. This causes the uterus to contract and expel the foetus within hours.

It is commonly administered during the first nine weeks of pregnancy but also within the second trimester and even then in conjunction with prostaglandin. RU486 can lead to serious side effects for those women who choose to end their pregnancy in this way. Women can experience internal bleeding and infection as a result of the retained parts of the foetus within the uterus. These women require urgent medical attention. In those cases where the use of RU486 has not worked, urgent surgical care and completion is required. In other cases, the mother experiences severe complications that can lead to death.

Currently, RU486 falls under a category of drug known as restricted goods—generally abortifacients—within the Therapeutic Goods Act. These goods must have the written approval of the health minister for evaluation, registration, listing and importation. Restricted goods provisions were introduced in 1996 and supported by both sides of the chamber. The amendments were based on the philosophy that the minister for health ought to be ultimately accountable for decisions in relation to the evaluation, registration, listing and importation of abortifacients because they are a special category of drugs which require additional public scrutiny. More than this, the Senate at the time recognised the health risks of the drug for women, including the damage to the long-term reproductive health of women and the risk of fatality. I agree with the position put forward by others that, in a case such as that of RU486, a sensitive community issue, it is not sufficient to assess only scientific criteria.

So now the situation remains that, should a sponsor wish to introduce RU486 into Australia, they must obtain written consent from the Minister for Health and Ageing before progressing to the Therapeutic Goods Administration. The Nash-Moore-Allison-Troeth bill which was debated and passed in the Senate last week seeks to remove the role of the minister from the approval process. Instead approval for the registration, listing and importation of the drug would rest with the TGA.

Firstly, I believe that this proposition removes ministerial accountability from the equation. I agree with the commitment of the Prime Minister and the Minister for Health and Ageing to ministerial accountability. Australia is an elected democracy based on an amalgam of responsible government and the Westminster system. I believe that we need to respect the office of the minister and the responsibilities and conventions that sit alongside it. Those of us who are privileged to serve our communities through election to parliament bear a grave responsibility. As elected officials, we are charged with making informed decisions on behalf of the nation and we are expected to be accountable for those decisions. In a case such as this, where we are dealing with a procedure inextricably linked to a sensitive community issue, one cannot remove ministerial accountability. We expect ministers to be responsible for making tough and sensitive decisions, and this case should be no different. At the end of the day the Therapeutic Goods Administration, with all its expertise, is not accountable in the same fashion as a minister of the Crown.

One of the reasons given to change the situation is to improve access to such procedures for women in rural and regional Australia. Women in these areas face challenges in gaining access to GPs and medical practitioners. The use of RU486 really does require strict supervision and is administered in many other nations within the context of a clinic. To provide it in any other way would actually present grave risks to any woman who chooses this option in rural Australia.

The amendment of the member for Lindsay strikes a balance between receiving scientific advice from the TGA and honouring the concept of ministerial responsibility. This amendment allows for the provision of RU486 to function as follows. Any sponsor seeking the listing, registration, evaluation or importation of RU486 makes application. The health minister receives written advice from the Therapeutic Goods Administration in relation to the safety and efficacy of the drug. The minister is then required to provide a written statement of reasons as to the approval or refusal to grant the importation. This advice is tabled in each house of parliament by the minister within five sitting days. The approval or refusal is a disallowable legislative instrument, meaning that in the case of grave concern the minister’s advice may be overturned, but only by the parliament. Parliamentary accountability is retained in the final decision.

There are an estimated 73,000 to 91,000 abortions in Australia every year. It seems to me that many feel their only options are to either keep the baby and struggle on—often alone and without support—or seek an abortion. Pregnancy is viewed through a lens, and a number of women feel as though their choices are limited. A third option, to complete the pregnancy and place the child in adoption, is often not encouraged and requires support and services. Last year there were only 70 adoptions across the nation despite the enormous estimated number of abortions. No matter what their age, women need support, advice and assistance for all options.

It is important for me to say that, while abortion is not an option that I would choose for myself, I am not here to judge those women who face enormous challenges. I do believe that women require advice about all options available and that support structures are critical to women being able to make real choices. It is important that we provide women with education on all options open to them, including adoption. In many other debates we focus on the value of humanity and the rights and responsibilities of individuals. I feel it is important to focus for a moment on the potential of the human life within the womb to have a future—a contribution unmeasured and significant, no matter how small or large, to a family, a community, a nation and, potentially, our world. In conclusion, I strongly support the amendment of the member for Lindsay and I do not support the private member’s bill.

Tony Windsor (New England, Independent) Share this | Link to this | Hansard source

Irrespective of the outcome of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, the debate has highlighted a very significant issue that I think this parliament should reflect on a little more: the issue of when members of parliament are given some degree of freedom in the way they vote. They do take it seriously. An enormous amount of research has been conducted by members on both sides of this issue, and I give credit to them. I think that is something that the executive government should pick up on as well. People are not sheep, if you like, in the major parties; they can think for themselves and express themselves very well on key issues before the parliament. I congratulate those people on the work and effort they have put in.

I support the legislation before the parliament today. I will not be supporting the proposed amendments. I see this vote as very much a vote about who determines the use of a drug. I do not see it in the light of the abortion debate. I have personal views on abortion, but this is not a debate on abortion. It is a debate about the assessment and regulation of a drug that is available in some parts of the world and may or may not become available in this part of the world. If this legislation is passed, it will not necessarily mean that RU486 will be available to the Australian population. It will mean that a medical process will take place to assess the safety risks.

I take on board the comments that the member for Calare made, and I understand some of those concerns—I think most people do. All drugs carry risk. This drug may carry risks as well. But I do not believe, as some people do in relation to the amendments to the bill coming before the parliament, that I have the technical skills to make decisions about this drug. I do not believe I have those skills in relation to other drugs. If we open up the debate that members of parliament should suddenly become experts on the use of and safety measures for drugs, we will have a whole range of drugs before the parliament asking for similar consideration. So I believe that the TGA, the medical experts, should be the ones who make the decision on the use of RU486.

We have heard the differing views within the parliament. There are medical practitioners, two of whom I listened to quite intently. I regard them as men of high esteem. They had differing views on this drug, and they are trained in the use of drugs generally and in patient care. A number of people in my electorate, as within all electorates, have raised concerns on both sides of the debate. I thank those people for the information they have transferred to me. I have to say that I thought many more constituents would have raised this issue, because on many other issues there has been much greater concern and personal interaction. I note that some of the members of parliament have done mini polls of their constituencies or have counted up letters for and against and come up with some indication of where their electorates are taking them. It is interesting to see that they do that, and I would encourage them to follow that particular line on other issues. I note that quite a lot of them did not bother to follow the so-called instructions of their electorates on some other important issues that have come before the parliament in recent months.

I listened quite intently to the Treasurer’s contribution this morning. The Treasurer spent some time talking about the personal dilemma that he faced in consideration of a termination some years ago in his life. I know that in my family we also have been touched by this issue in years gone past. I took on board the concerns that the member for Riverina raised—and I do not want to verbal her—about her not wanting to be put into the situation where she would have to make that decision. I think she made a valid point: it would be a hard decision to make if you were placed in that position. Unless people have actually been there they really cannot know what that sort of decision process is about.

In saying that I think we really must respect the choice that women of varying ages have to make—they might be young girls or they might be women in their 40s. It is not an easy choice. I personally do not feel that I want to be in the position of removing a particular choice about how a legal abortion can take place. Abortion is legal on the state statutes, and I do not want to be in the position of deciding how that process can be conducted. Some regard has to be taken of the process that the TGA will use in its assessment of this drug. In supporting this bill I am not supporting the use of RU486; I am supporting a legitimate medical process to determine whether this drug is safe and whether it should be assessed as suitable for treatment within Australia.

I am not a medical person, and so I do not have the expertise, but there may well be certain restrictions that could be placed on its use in relation to distance from medical facilities. There may well be some restrictions about the clinical use of the drug. There may be recommendations that if you live in certain areas this drug may not be as safe as having a surgical abortion. One thing is for sure: if the TGA does legitimise the use of this drug, there will be pressure on the recommendations of GPs for its use and on the relationship between patient and doctor. Real pressure will be put on those people to make sure that some of the things that have been talked about here—for example, picking up the drug and just wandering off into the bush and carrying out an abortion at home—cannot occur and that there is close contact between the medical practitioner and the woman concerned.

There are a couple of other issues that I would like to raise. I think most of us have seen from time to time that one of the worst things we can do is have people having unwanted children. There are two issues here: the woman concerned and, obviously, the foetus. We have too many unwanted children in Australia now for whom we are trying to pick up the pieces and patch together their lives. The last thing we really should be encouraging is for women to be mothers who do not want to be mothers, irrespective of their age, and not being given the choice of being able to terminate that pregnancy.

I conclude by reiterating that the safety issues that the member for Calare and many others have spoken about really do have to be discussed both within this place and within the processes of the TGA. Proper protocols need to be put in place so that a lot of concerns that many people within the parliament have in relation to this issue can be alleviated.

I would highlight, particularly to my constituents who have concerns about this debate, that most of the letters I have received—and, as I have said, I have not received a great number of them—that are opposed to the legislation or are suggesting that I should vote against RU486 or the TGA being the determining body for the usage of it have essentially talked about the issue of termination of pregnancy rather than the issue of who makes the determination as to whether the drug in question is used. As I said at the start of my contribution, I will be supporting the legislation before the parliament, and I will not be supporting the two amendments that are being proposed.

Gary Nairn (Eden-Monaro, Liberal Party, Special Minister of State) Share this | Link to this | Hansard source

The first thing I would like to say in speaking in this debate on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is to generally thank the many people of Eden-Monaro for their emails, letters, faxes and telephone calls offering their view on the bill. It is important for all members to listen to their constituents. However, I say ‘generally thank’ because unfortunately there have been contributions from just a few constituents that, in all honesty, I cannot say thank you to. I hasten to add that the contributions I refer to have come from both sides of the debate—as members would expect, both extremes of the debate. One measured contribution encouraged me to vote on this bill according to my conscience and not on emotional or religious grounds. I can assure all constituents of Eden-Monaro I will not be voting on either emotional or religious grounds.

I have also been reminded that this debate is not about abortion. This is absolutely correct, but unfortunately many of the people encouraging me to oppose this bill have argued strongly against abortion. Also, many people encouraging me to support the bill have done so on the basis of being strongly pro-abortion. Both of these arguments are not appropriate for this bill. If passed, this bill simply takes the responsibility to register a particular drug away from the Minister for Health and Ageing and places it in the hands of the Therapeutic Goods Authority. It has no impact on the legality or otherwise of abortion.

Much has been argued about which of these two should have that responsibility. If it remains with the minister, the minister of the day could take whatever advice he or she believed appropriate before making a decision. The TGA has a process for determining the safety, efficacy and quality of all drugs that are lodged with it seeking registration. What has not been stated very widely is the detail surrounding an application to the TGA and subsequent to the registration if successful. Firstly, an application for registration to the TGA must be submitted in a specified format, which includes the provision of detailed documentation about the conduct and outcomes of clinical trials in humans in order to establish the product’s safety, efficacy and quality. The data submitted are subject to extensive review by the TGA staff and contracted clinical experts. A summary of the TGA’s evaluation of the application is then put to the Australian Drug Evaluation Committee—ADEC—for advice. If registered by the TGA, restriction on the availability of mifepristone, or RU486, can occur on a recommendation by the National Drugs and Poisons Schedule Committee to the states and territories.

Other restrictions on use which might possibly be recommended by ADEC or be a condition of registration imposed by the TGA, such as limitation of prescribing to medical practitioners who have undergone some form of additional training, can be enforced by the state and territory governments, who control medical practices. Therefore, there is substantial opportunity for the many people who have argued abortion specific matters in this debate to have input not only to the TGA but also to the Australian Drug Evaluation Committee, the National Drugs and Poisons Schedule Committee and their respective state and territory governments. My unemotional, considered view of this matter is that the TGA is the appropriately constituted and qualified body to carry out the necessary independent investigations to determine whether RU486 would be registered if such an application was made. I would also add that the TGA would determine the conditions under which such a registration was made if it determined a registration was warranted.

I am well aware my decision will disappoint many constituents—probably anger many as well. Many in that category are close friends and supporters. Equally, my decision will be welcomed by many. To both those disappointed and those pleased, I emphasise that my vote is not a vote in favour of widespread abortions. Irrespective of the circumstances, I remain strongly of the view that the termination of a pregnancy is a matter for the mother and the father and their health professional. Any individual placed in such a traumatic circumstance is under enough personal strain without added political pressure. For that reason as well, I do not support the amendments proposed as they would simply ensure multiple divisive debates in this House in future years that would only further encourage the two extremes of the abortion debate and do nothing for those having to deal with personal trauma. I intend voting in support of the bill as first introduced.

Carmen Lawrence (Fremantle, Australian Labor Party) Share this | Link to this | Hansard source

I am sure that many members have spoken with such conviction about their view on ministerial and parliamentary approval for RU486 without fully understanding the process by which it was singled out from other drugs normally approved by the TGA. I have been around a little while, and I am aware of what happened in 1996. It is useful to remind members of the history of this decision. It was not the result of careful analysis or an extended parliamentary debate like this one. Rather, it was a deal done when the government did not have control of the Senate to secure Senator Harradine’s vote for the sale of Telstra and other matters. It was never a matter of high principle. Rather, the women of Australia were denied access to what has now been shown to be an effective and medically approved method of terminating pregnancy because of what was effectively a political deal. To my dismay, and contrary to the views of many of our members at the time, it was not opposed by Labor in the Senate either.

During 1994, when I was Minister for Human Services and Health in the Keating Labor government, trials of RU486 were being conducted in Australia as part of a multitrial program sponsored by the World Health Organisation. The trials were conducted at the Sydney Centre for Reproductive Health, which examined the use of RU486 as an emergency post-coital contraceptive, as they described it, and by the Monash University Department of Obstetrics and Gynaecology at the Family Planning Association of Victoria, who were assessing the effectiveness of combined RU486 and prostaglandin as a method of early pregnancy termination.

In May of that year, as part of his continuing campaign—which I respect—to stop abortions in Australia, Senator Harradine raised questions about the TGA approval for the import of the drug and the ethics committee processes which were in place for the trials to get informed consent from the women. Controversy surrounding the trials came to a head in late 1994 following an article in the Canberra Times which expressed concern about whether women in the trials had actually been given sufficient information to give properly informed consent. A number of pro-choice women active in family planning were also concerned that:

Compared with existing methods of abortion ... It has a greater degree of nausea, pain, prolonged bleeding  ...

Women coming to the Family Planning Association in Victoria in particular, as one woman put it, ‘come expecting to get a curette and they’re being coerced into volunteering for a trial’. At the same time, the Catholic bishops—the feminists and the Catholic bishops was an unusual combination of forces which I do not think we have seen for some time—took the opportunity to lobby the Prime Minister, without success as it turns out, to prevent the trials continuing. They said publicly that they regarded me as a lost cause—my views are well known on this matter—although I was in fact concerned that the processes for obtaining informed consent from the women in the Victorian trial may indeed have been inadequate.

After discussions with those conducting the trials in Victoria, the trials were actually suspended to allow an examination of the ethics and consent procedures by a consent review panel consisting of Bryce, Clarke and Funder. I also established a separate review into the operation of institutional ethics committees more broadly to ensure that ‘they are as effective as possible in overseeing and monitoring clinical trials’.

Once the Victorian panel had reported and its recommendations had been incorporated into the trial’s protocols, the trials resumed and concluded. The Committee on Institutional Ethics that I had set up subsequently reported to Dr Wooldridge, the then Minister for Health and Family Services, following the change of government, and many of its recommendations were subsequently incorporated into institutional ethics protocols and do deserve to be reviewed from time to time. The results of the trials, reported in 1997, confirmed international evaluation and indicated that RU486 could be used safely, with many women in fact expressing a preference for such medical termination over surgical procedures.

But in the meantime, in 1996, soon after the current government was installed, Senator Harradine was successful in inserting ministerial approval for RU486 into the Therapeutic Goods Amendment Bill, which was before the House at that time. This of course was not recommended by either of the committees that I referred to that had assessed the question of the conduct of the trials. The matter was never fully canvassed within my own party or, indeed, within the wider community and several members, including me, argued vehemently against supporting the Harradine proposal.

As a result of the deal that I mentioned, a special category of drugs, to include RU486, was created for the first time in 1996. Under the Therapeutic Goods Act, these ‘restricted goods’, as they are described, cannot now be evaluated, registered, listed or imported without the express written approval of the minister for health. In those amendments, restricted goods were defined as medicines ‘intended for use in women as abortifacients’. In other words, the restricted goods provisions apply exclusively to medicines intended to induce an abortion.

As members well know—they will have at least heard the discussion—all other medicines used for any purpose other than abortion are evaluated and regulated by the Therapeutic Goods Administration without any requirement for approval from the Minister for Health and Ageing. The TGA provides a scientifically rigorous and comprehensive process of assessment for drugs and other therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and medical devices. Like other government departments, of course, it is answerable through the responsible minister to this parliament.

Under the present act, a sponsor seeking approval to market an abortifacient can apply through the same process as exists for all prescription medicines in Australia—that is, an application would need to be submitted with supporting data to demonstrate the quality, safety and effectiveness of the drug. The key difference as a result of the restricted goods provisions is that, in addition to the supporting data, written ministerial approval is required before a restricted good such as RU486 can even be evaluated by the TGA. I think it is fair to say that there is no guarantee that this Minister for Health and Ageing or any other—it is not personal—would be guided by the same careful and dispassionate assessment of the drug that is required of the TGA. In any case, such a person would be unlikely to have the expertise.

At the time the amendments were agreed, some senators predicted in the debate that potential sponsors might make the judgment that it would not be worth their while to make application because of the likely expense and controversy surrounding the ministerial decision. Whatever else we might say about those who oppose abortion on any grounds, they are very public, persistent and sometimes emotive. Not all drug companies are willing to subject themselves to such opprobrium. Perhaps as a result, and as was predicted at the time, no application has ever been lodged in Australia despite the fact that, strictly speaking, it is possible to apply for approval to market RU486. The fact that RU486 is currently licensed for use in a large number of countries apart from Australia lends credence to the view that the current legislation represents a barrier to potential sponsors seeking approval. That is why this legislation is necessary, and I welcome it, and it is why the amendments should be rejected.

All the evidence suggests that, given the choice, a substantial proportion of women prefer medical methods of abortion and that it is safe to do so. I quote from the International Planned Parenthood Federation:

There is overwhelming evidence, based on numerous studies and clinical trials to support the statement that this drug is safe and efficacious for medical abortion.

Of course, that has to be assessed in Australia by the TGA. After reviewing existing literature and the results of clinical studies and trials on RU486 for medical abortion, they found unanimously that the drug is safe and effective. As members also know, the WHO has declared medical abortions safe, effective and acceptable if the few conditions which warrant control are identified and post-abortion care is available. No procedure, as members know, is without risk—and nor is child birth. We live every day, consent to drugs and are subjected to medical procedures with known and measurable risks and side effects. And we do so after these drugs and procedures have been meticulously evaluated by the TGA and following medical advice. RU486 should be no different.

I want to end on this note. Like most people, I believe it is desirable to reduce the need for terminations by reducing the number of unwanted pregnancies, not by restricting access to terminations. Most women, their partners and their families would prefer not to be in the position of having to decide whether or not to terminate in the first place. Although we have to accept the fact that contraceptive methods are not foolproof, we can do a lot more in Australia to reduce unwanted pregnancies. Other wealthy nations have lower rates of abortion than we do. I would argue that we need more comprehensive and sustained sex education for young people and a greater willingness to talk frankly to young people about responsible relationships and the risks of premature sexual activity.

We need more easily accessible and affordable family planning information and advice. We need more professional counselling for people with psychological problems, who are sometimes at risk of an unwanted pregnancy. We also need more readily available contraceptives, especially for younger people who are sexually active, and serious strategies to reduce violence, especially sexual violence, in relationships. Women subjected to such violence often seek to end their pregnancies—perhaps understandably. If we adopted such an agenda and promoted it with some energy, we would have fewer unwanted pregnancies and fewer abortions in this country—a goal I am sure we all share.

Patrick Secker (Barker, Liberal Party) Share this | Link to this | Hansard source

We have a conscience vote on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. It is my second in 7½ years, so it is not often that as members of parliament we get the opportunity to have a conscience vote without any pressure from parties, prime ministers, leaders of the opposition and so on.

It has been very interesting to hear the different arguments put forward by members in their contributions to the debate on this bill. I agree with many of the arguments that have been put forward by those members whose vote will be quite different from mine. For example, I agree with the suggestion by the previous speaker, the member for Fremantle, that we need to do more to reduce abortions by providing better sex education and availability of contraception. But I could not be further from her view on where she will be voting.

Like every other politician here, I have received a lot of emails, phone calls and letters about the bill. Interestingly, in my electorate I think two people have suggested that I support the bill and, at last count, about 60 against. Even on that representation, my electorate seems to be a little different from others. In the end this is a conscience vote, and we as politicians have a duty to vote according to our consciences, which can never be the same as those of our constituents. I am sure that some will agree with me and some will disagree with me.

There are two questions to ask when referring to this bill. The first question is: who makes the decision about this drug? I have heard the various arguments that this drug should be dealt with in the same way as every other drug in this country. But not every other drug in this country causes abortions. The second question is: is this bill about abortion? Whether the bill is technically about abortion or not, most members have referred to abortion and expressed their views on it. It is very hard to divorce yourself from your beliefs on abortion, and for many it is the reason they will be supporting or opposing the bill. And I am the same: I will oppose it because of my belief in the sanctity of life.

It is interesting that we have four choices on this issue. We have the status quo, where the Minister for Health and Ageing has the veto power. That could vary quite considerably, depending on who the minister of the day is. I think the first amendment—the ‘Jackie Kelly amendment’—is the best course of action. Failing that, I would support the ‘Andrew Laming amendment’. If both amendments fail, then I would oppose the bill, which is the fourth choice. I will explain to the House why I have that view. I have heard many speakers say that this bill is not about abortion but about what is the best way to decide on a drug. That might be the technical argument that we are looking at, but out there in voter land I can assure you that this bill is about abortion. The voters have certainly expressed to all of us that they believe this bill is about abortion—with one argument about the right of women to do what they shall with their own bodies and the other about abortion being wrong. While most of the speakers in this parliament have said this is a technical argument about the best way to make a decision, I do not think any of us could say that the whole theory and philosophy about abortion has not come into this argument.

Normally, it is a state government decision. State governments all around Australia, with varying conditions, have legalised abortion. That has been the case for some time now. If I were in state parliament I would have voted against those decisions, but I have never been in state parliament. Thankfully, I am in federal parliament and, normally, we do not have to make these decisions because they are the prerogative of state governments. But, because we are talking about the importation of a drug into Australia, it now becomes the role of the federal government to make that decision.

I am concerned that, if this bill is passed, we will be taking away the role of politicians to make a decision on what is a very strong and ethical issue for many people and giving it to bureaucrats who do not have to face up to the public. I have heard the arguments that we can come back and reject that decision later, but that is all much harder to do. It worries me that some people in this parliament are willing to take away the responsibility from an elected politician and give it to an unelected bureaucrat. There has been too much of that in probably the last two decades. I remember having a discussion about this with a well-known person—and I do not need to name him—but he thought it was a worrying trend also. He was hoping the trend to give the responsibility for making decisions to unelected bureaucrats rather than to politicians who are doing their job and making the decisions themselves would be reversed.

We have heard all the arguments about whether RU486 is a safe or dangerous drug. I am sure the TGA can judge that. But this is not about judging whether a drug is safe or considering the efficacy of it. I reject all those arguments. It is all about whether we should have drugs for abortion. This is my only opportunity, as a pro-life person, to oppose this bill because of that sentiment. I have another concern if RU486 is eventually legalised. Every politician in this House—and probably many other people out there in their electorates—get bombarded almost hourly with advertisements on the net for Viagra, Cialis and so on. Of course, we automatically delete them because we are not interested in them. This bill will give people the opportunity to buy this drug over the net and have it imported into this country legally.

There is nothing in this bill that actually says that we will be stopping RU486 from being imported over the net. The trouble with that is that it will be done without medical supervision. Anyone who has spoken about this drug has always added the rider that, if you use this drug, it should be with proper medical supervision. But, if you are buying it over the net, that supervision will not be there, and that has to be a concern that has not been addressed by this bill at all. Like it or not, this bill has become a bill about abortion—that is fact and perception. As I said, I am unashamedly pro life, not because of religion but because I believe in the sanctity of human life.

So who should make the decision—not who should give the advice? I think we have been a bit confused here. We should always accept advice from the TGA on a decision like this. We should always accept advice from experts, whether it is advice from the TGA or from scientists or whether it is accepting what has happened overseas. But that does not mean they make the decision. Politicians are elected to make decisions; bureaucrats are there to give us advice. And to give the responsibility of making this moral and ethical decision to unelected bureaucrats is the basis of my rejection of the bill’s amendment. Firstly, I will support the amendment moved by Jackie Kelly and, if that fails, I will support the proposed amendment of Andrew Laming. I believe we are elected to make these decisions, not bureaucrats.

If we pass this bill, we will be the first parliament in Australia to give the responsibility of making a decision on abortion to unelected bureaucrats. I think we need to make that point very clearly: we will be the first parliament in Australia’s history to give the responsibility of making a decision about abortion to bureaucrats. We can accept that advice, but I assure you that in every state parliament of Australia they did not give the decision making on abortion to bureaucrats; they had the guts to make that decision themselves. But this bill does.

As I said, we have had a fairly long and protracted debate about this. There will be more to come. I am not sure whether there are many new areas that we can traverse in this debate. But I cannot divorce myself from a position where everyone knows that there is a feeling and a perception out in the community that this debate is really about abortion. My feeling about the bill is that it does not give enough protection against the ability to buy this drug on the net without any medical supervision. I think everyone would suggest that, if this drug is ever going to be used, it should have very strict medical supervision.

In closing—I see many of my colleagues have come into the chamber—I do not reflect on the decision of any of my colleagues. We all have a conscience and we all have to live with that conscience. My conscience tells me that I cannot support the bill. Firstly, I will support the amendment moved by Jackie Kelly. Secondly, if that fails, I will support the proposed amendment by Andrew Laming. If all else fails, I will oppose the bill.

David Hawker (Speaker) Share this | Link to this | Hansard source

Order! It being 2 pm, the debate is interrupted in accordance with standing order 97. The debate may be resumed at a later hour.