Mal Washer (Moore, Liberal Party) Share this | Link to this | Hansard source

I move:

That this bill be now read a second time.

The history important to this debate on RU486 (mifepristone) comes about because this drug belongs to the special category of drugs under the Therapeutic Goods Act 1989 (the act) known as restricted goods, which cannot be evaluated, listed, registered or imported without the written approval of the minister for health.

Further, any such written approval must be laid before each house of parliament by the minister within five sitting days of being given.

Restricted goods only apply to abortifacients—that is, exclusively to medicines intended to induce an abortion.

All other medicines are evaluated and regulated by the Therapeutic Goods Administration (TGA) without any requirement for approval from the minister.

A sponsor seeking to market an abortifacient such as RU486 would need to submit an application with supporting data demonstrating quality, safety and effectiveness of the drug through the same process as all prescription medicines in Australia. The key difference is that in the case of RU486 ministerial written approval is required before evaluation by the TGA can occur.

The restricted goods provision was incorporated into the act in 1996 as a result of amendments introduced in the Therapeutic Goods Amendment Bill 1996 by Senator Brian Harradine.

The amendments were supported by both the Liberal-National Party government and the Labor opposition.

This made the minister for health, rather than the TGA, ultimately responsible for decisions in relation to evaluation, registration, listing or importation of abortifacients.

Senator Meg Lees argued at the time that this would effectively deter sponsors from seeking to bring RU486 into Australia, an argument that has proven to be true. Please do not confuse authorised prescribers as changing the restricted goods status of this drug.

Sponsors often face significant costs in putting together supporting evidence for an application to the TGA, which demands full cost recovery.

The TGA is a globally respected organisation and is the appropriate authority to assess and evaluate the risks posed by therapeutic goods, applying any measures necessary for treating the risks posed and monitoring and reviewing the risks over time. So far the TGA has been entrusted by government to evaluate more than 50,000 therapeutic goods. Therefore, it would be reasonable to assume that it is also qualified to manage the risks associated with medicines such as RU486.

In 2005 two Queensland based gynaecologists, Caroline de Costa and Michael Carrette, submitted an application to become authorised prescribers of RU486. This was referred to the TGA by the minister.

A TGA bill before the Senate gave Senators Lyn Allison, Judith Troeth, Fiona Nash and Claire Moore the opportunity to change this ministerial control in the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005.

This bill will ensure all medications for use in Australia are appropriately evaluated by the TGA and the Australian Drug Evaluation Committee, the group of independent experts appointed by the health minister.

The member for Murray, Dr Sharman Stone, supports this position, as she has experienced the plight of disadvantaged people in her electorate in having only a ‘surgical requiring anaesthetic’ option for termination of pregnancy.

Clearly this debate is not about one’s views on abortion, as this is a legal procedure determined by state and territory laws. There should be no difficulty in separating the issue of abortion from the question of method.

Currently this parliament sanctions and Medicare rebates surgical—that is, suction curettage with anaesthesia termination of pregnancy—a procedure with many similar risk factors to RU486.

The reasons for abortion are an unwanted or unviable pregnancy. Unwanted pregnancies occur in multiple situations such as foetal abnormality, serious maternal health problems and severe psychological and social problems, to mention a few.

This debate is not about increasing the incidence of abortion, as careful research in many of the 35 countries where RU486 is used has not demonstrated this trend.

In the Netherlands, where abortion is legal and both surgical and medical—RU486—methods are available, and contraception and sex education are widely promoted, there exists one of the world’s lowest abortion rates.

In Australia, where RU486 is not available, the incidence of abortion is far too high, and we should take some lessons from the Netherlands.

As Dr Stone and I have advocated, we need to put in place better education and information programs that more effectively inform young people about their own sexuality, that empower them with better life skills and that teach them about responsible parenting and contraception. There is an urgent need to identify world’s best practice, with a view to our government implementing a national health and wellbeing program that is available in all schools.

As the highest rates of abortions occur in women between 20 and 24 years of age, there is also a need for media education similar to our highly successful tobacco Quit program.

This debate is not about parliamentarians rightly being entitled to different views on abortion, as there are many members with religious and moral views who oppose abortion.

Nevertheless, politicians are not entitled to use the power of the state and legislation to impose their own personal moral positions on the entire community.

We do have a political responsibility to ensure the safety and quality of health care and to ensure equitable access to lawful services and procedures.

There can be no excuse in this debate to confuse separating the issue of abortion from the method of abortion, particularly when the surgical method receives Medicare funding.

I would have thought that Christian belief would extend compassion to women confronted with unwanted pregnancy, particularly with gross foetal abnormality and serious maternal illness including cancer, and in cases of nonviable pregnancy and to at least allow the dignity of a thorough evaluation of a medical alternative.

This is not a debate about confidence or lack of confidence in the health minister, a man whom I believe has excelled in the job. We may have had a few minor differences but that is expected in any mature political relationship.

The debate should not be influenced by extreme minority groups targeting marginal seats, aimed at intimidating people in these seats to confuse the debate as a debate about the pros and cons of abortion, which is a total lie.

The debate is certainly not about giving parliament greater levels of scrutiny and accountability by ministerial retention, now or in the future, of the power that requires his or her written approval for TGA assessment.

Under the current arrangements the health minister is simply required to notify the parliament of a decision to approve the application for evaluation of an abortifacient by the TGA.

Given the fact that such a decision is not disallowable, this would not amount to a significant level of parliamentary scrutiny.

Further, the minister is not required to table decisions not to approve such applications, meaning that the parliament would neither necessarily be informed nor have the capacity of any oversight of such a decision.

A proposition put by some that the bill, if approved, would abandon parliamentary responsibility to grapple with difficult social and ethical questions instead of leaving this to scientists, doctors, ethicists and officials specialising in the field but who are not as accountable for contentious decisions is, to say the least, ludicrous.

How many times have we rightly heard statements like, ‘I will take advice and report back to parliament,’ or, ‘We will await the outcome of an expert inquiry,’ or, ‘This is just a download from Google and not properly researched policy’?

Specialised scientific and medical advice built on evidence based research and expertise is the only way to determine appropriate methods of treatment.

These methods also need to be followed or reviewed on a regular basis to ensure safety, and funded by a sponsor.

Further evidence to confirm this absurd position will be ‘cherry-picking’ of risk factors of RU486 to suit an argument to effectively prevent proper evaluation by the TGA.

For example, I am sure one will be clostridium sordellii, which can cause septic shock. It is an organism found in soil and in the human gut and in 10 per cent of women’s vaginas. This will no doubt get a mention.

The four deaths in the USA and one in Canada associated with abortion are factual, but the FDA is not convinced that they are directly related to RU486 or prostaglandin usage.

Infection from this bacterium has occurred in people undergoing liver, colon, bowel and prostate procedures and has been associated with ear infection, wound infections and caesarean section. These types of infections are certainly not beyond our medical ability to prevent by the use of appropriate prophylaxis if deemed necessary, no doubt a job for the TGA to assess.

A number in this debate will talk of the drug in the light of medical misadventure or incompetence, a problem that makes any medication look dangerous if inappropriately administered or managed but of course not the fault of the drug itself.

Others will claim this drug is evil because it is designed to kill a foetus, but so of course is the Medicare rebatable surgical procedure of suction curettage with anaesthesia.

It is interesting to note that maternal death from pregnancy giving live birth is almost seven times greater than medical or surgical abortion, yet few of us would discourage women from having children.

I have no intention of pretending expertise in RU486 and prostaglandin combination usage, as it has never been utilised in this country, although of course prostaglandins have been extensively utilised on their own for a number of purposes.

There seems no doubt, however, from overseas experience that in the period of pregnancy before eight weeks gestation, when suction curettage can be used without greater risk of cervical and uterine damage, RU486 is a much safer option.

We almost all agree that, if abortion is deemed necessary, earlier rather than later is preferable.

Abortifacients like RU486 are already used in this country for termination of ectopic and intra-uterine pregnancy.

Methotrexate, a drug readily available, a folate antagonist, is used in certain cancers, psoriasis and rheumatoid arthritis and is one of these drugs. However, methotrexate lacks the efficacy and safety of RU486 for intra-uterine abortion.

I have always believed, like the majority of people in this place, that freedom of choice should be a right of all, within the constraints of the law. Women undergoing legal procedures should have the opportunity to have proper assessment of the medical alternative to surgery, otherwise there would be a lingering doubt that this is more about punishment than the responsibility of ensuring the best care possible.

The best care possible is determined by the TGA, with informed consent and, I emphasise, appropriate counselling between the patient and doctor, a view supported by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Australian Medical Association, the World Health Organisation and the Public Health Association of Australia, to mention but a few.

The TGA will enable us, as politicians, to ensure that the best scrutiny is given to RU486.

It is anticipated that adequate funding by a sponsor will be offered to introduce the medication to Australia if the current ministerial requirements and impediments are lifted. Not removing these impediments is an exercise in gross negligence to a section of our constituencies.

It is time for us to minimise the trauma to women undergoing a legal procedure for an unwanted or non-viable pregnancy. This debate is about method and definitely not about abortion, so we have no need to take the place of our state or territory politicians who have already legislated on the matter of abortion. Please also remember that women would not be pregnant without at least some assistance from a male and that the trauma associated with abortion extends beyond the individual to family and friends. A very significant part of that trauma is related to the method of the procedure. This is where this debate should remain acutely focused.

Any amendments presented in an attempt to politically dilute or pervert the findings of the TGA should be vigorously rejected.

Would anyone in this House seriously believe that any CEO of a sponsor company would sanction the very significant time and money to seek approval for a drug to be TGA assessed when this parliament could reject it out of hand?

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

Is the motion seconded?

Julia Gillard (Lalor, Australian Labor Party, Shadow Minister for Health and Manager of Opposition Business in the House) Share this | Link to this | Hansard source

I second the motion and welcome the opportunity to speak in this debate on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. I congratulate the member for Moore, whom I am following, on the role he has played in this debate, and of course Sharman Stone, now elevated to the Howard government ministry. I also offer my congratulations to Senators Moore, Allison, Troeth and Nash. I note that my Senate colleagues Senators Moore and Webber are in the gallery watching this debate.

I would like to make some comments today on what this debate is about, who this debate is about, the effect of the amendments which are to be moved and which are before the House of Representatives for its consideration, and the role of the Minister for Health and Ageing in this debate. This debate is of course about RU486, which belongs, as the member for Moore has said, to a special category of drugs under the Therapeutic Goods Act 1989 known as restricted goods. These restricted goods are defined under the act as drugs intended for use in women as abortifacients. The special category of drugs cannot be evaluated, registered, listed or imported without the prior written approval of the minister for health. A written approval must be laid before each house of parliament by the minister within five sitting days of it being given.

The regulations that ban the importation, trial, registration or listing of RU486 and similar abortion drugs without the written approval of the minister for health were incorporated into the Therapeutic Goods Act 1989 as a result of the passage of the Therapeutic Goods Amendment Bill 1996. The provisions relating to RU486 and the role of the minister for health were introduced into the 1996 legislation as a result of an amendment introduced by Senator Brian Harradine. This came about because Senator Harradine was concerned that RU486 had been allowed into Australia as part of two World Health Organisation sponsored clinical trials. One was in New South Wales and one was in Victoria. At the time of the amendment, Senator Harradine and those who supported the amendment restricting RU486 argued that the long-term health effects of using RU486 were unknown and therefore additional scrutiny was required. That argument may have had some merit in 1996, but 10 years on, with the drug now having been used by 2.5 million women, these arguments no longer have force.

It has been noted in the course of the public debate about RU486 that Labor members supported this amendment. It was done on the voices. But when one looks at the Hansard record of what motivated Labor members at that time it is clear that they thought there should be some extra scrutiny of RU486 but they did not believe that what they were putting in place at that point would amount to a complete ban on RU486. That is made clear by the words of the then shadow minister for health, Michael Lee, amongst others. It has in effect become a complete ban, for the reasons that the member for Moore has gone to. The manufacturer of RU486 and the people who would seek to import RU486 are not going to do so if they have to face the uncertainties of a political process, whether that be a political process involving ministerial approval or, indeed, a political process involving parliamentary disallowance, as the amendment which is to be moved to this bill suggests.

It has been an effective ban. We know that RU486 has not become available in Australia. Obviously, given that it is now off patent—so that the amount of money paid for the drug and the reward to the manufacturer are therefore necessarily quite low—and considering the time and cost that would be involved in filing an application for TGA approval, it is unsurprising that an entity making a commercial decision in the face of political hurdles has decided not to even enter the race which ultimately would have made RU486 available.

The bill before us would change the system. It would remove the requirement that RU486 and other designated abortifacients obtain the permission of the Minister for Health and Ageing for importation, trial or listing. The permission of the TGA would still be required, as would ethics approval. In my view, this puts RU486 where it belongs: to be treated like any other drug being imported, trialled, prescribed under the Special Access Scheme or submitted for registration in this country.

The bill before us today is about neither whether abortion should be legal in this country—that is not a decision for this parliament under our current political and legal system—nor whether a medical abortion is legal. This bill is about whether the best method to assess RU486 for safety should lie with the Therapeutic Goods Administration or with the minister for health. In my view, it should lie with the Therapeutic Goods Administration, which we trust to assess the safety and effectiveness of tens of thousands of medicines, many of them dangerous—many of them dangerous new cancer medicines, many of them dangerous and addictive pain-killing medicines, many of them medicines which, if misused, can cause real human distress. We trust the Therapeutic Goods Administration to do that for tens of thousands of medications and drugs. I believe that we can trust the Therapeutic Goods Administration to do that for RU486. The impact of this bill is to give the Therapeutic Goods Administration the power to do the work in respect of RU486 that it is empowered to do in respect of other drugs and medicines—work that it has done successfully for tens of thousands of drugs.

If this bill were adopted, the way in which the system would function for RU486 would be as follows—and we need to note that RU486, because it has not been registered in Australia, for the reasons of which I have spoken, has not been approved for use in Australia. If this bill were adopted and the drug were then imported to Australia for use in clinical studies or under the Special Access Scheme for individual patients, all submissions for importation would have to be approved not only by the Therapeutic Goods Administration but also by the relevant ethics committees that would work on this issue. So we would have two layers of checking: the TGA and the relevant ethics committees. If an application were made for registration of the drug for sale in Australia, this application would have to be considered by the Australian Drug Evaluation Committee, the ADEC, which is an expert advisory group appointed by the minister. Given these layers of checking—if the drug remains unregistered, it goes to the TGA and then an ethics committee; if registration is sought, the TGA and the Australian Drug Evaluation Committee are involved—I ask the question: what further work is it that political intervention by any minister for health could do? The system is robust and should be allowed to do the work that has been set for it, and that is what this bill would achieve.

Having addressed the question of what this bill is about, I want to speak briefly about who this bill is about. In some of the public commentary there has been the image that women will be irresponsibly purchasing RU486, if it is available in Australia, to unthinkingly procure an abortion, or that this is a debate about irresponsible young girls or irresponsible young women. The evidence, whether we like it or not, is to the contrary. There is no evidence that Australian women have abortions unthinkingly. We know that over the past decade the proportion of Medicare funded abortions done for teenagers has fallen by 12 per cent—and that is a tremendously good thing—but the proportion for patients over 35 has risen by 37 per cent. We also know that a patient seeking an abortion was 40 per cent more likely to be married or in a de facto relationship in 2002 than in 1992. Any imagery in this debate of irresponsible young girls is false imagery and not imagery that we should allow to cloud our opinion. It seems that abortions are being had by women in committed relationships in the older age range. We do not necessarily know why, but I say that we should respect their decision because we will never know as much about their individual circumstances as they do.

Having addressed what this debate is about and who this debate is about, I want to spend some time talking about the possible amendments to this bill that have been foreshadowed in the House of Representatives. I note that some of the proponents of those amendments are here today, sitting in the House, listening to the debate. I understand that the amendments are put forward in absolute good faith and they will be spoken to at the appropriate point. But I cannot agree with them, and I will outline my reasons for not agreeing with them at this stage.

Two amendments have been foreshadowed. One has been proposed by the member for Lindsay, who is here now. Currently, as we have discussed, the Minister for Health and Ageing has the ability to approve or not approve the importation of RU486. Under the member for Lindsay’s amendment, the minister would still retain this power. However, after the minister had made a determination, whether positive or negative, the determination would become a disallowable instrument.

This is flawed on two counts. Firstly, the very thing that has made the current scheme of arrangements for RU486 an effective ban—the very thing that has driven that result—is the fact that there is a level of political decision making and uncertainty for a manufacturer or importer. The amendment suggested by the member for Lindsay would make this problem worse. A manufacturer or importer would not only need to go to a ministerial level but would also need to submit themselves to the vagaries of a parliamentary debate on a disallowance motion. I believe that would in effect be a continuation of the ban, because the manufacturer or importer would not run those risks. So, whilst I understand that the amendment is put forward in absolute good faith, I cannot agree with it. I think it would mean a continuing effective ban on RU486 and would introduce a new level of uncertainty.

I also note that the amendment would have the capacity to significantly impact on the work of this parliamentary chamber and the other place because one could anticipate that we would face very regular disallowance debates on RU486. I leave members to contemplate whether they think that is a desirable prospect. A disallowance debate could be triggered by any individual decision of the minister. Those decisions could be made on a number of applications for importation—an application for registration, an application to vary that registration and the like.

An amendment has also been proposed by the member for Bowman. This amendment is in some ways comparable to the amendment moved by Senators Colbeck and Scullion in the Senate, which I note was defeated, but it is also slightly different. The key difference between the amendment proposed by the member for Bowman and the amendment proposed by the member for Lindsay is that, under the member for Bowman’s amendment, there is no continuing role for the Minister for Health and Ageing. Under this amendment, a decision by the Therapeutic Goods Administration to register or list RU486—that is, any determination that RU486 is safe and effective—would be a disallowable instrument. It should be noted that once again there may be more than one such determination. For example, the TGA could make separate decisions on different applications for RU486 from different manufacturers. In my view this amendment is different to the amendment proposed by the member for Lindsay in that it is less likely to trigger multiple RU486 debates, but it is still possible that the parliament could find itself debating this matter on more than one occasion.

It should be noted that the definition of ‘restricted goods’ under the member for Bowman’s amendment is wider than RU486 and abortifacients and would include a range of yet to be developed drugs such as those to improve brain performance. My central criticism of the member for Lindsay’s amendment stands in relation to this amendment. Once again, if you inject this level of political intervention in the process and the uncertainties of what would happen in a disallowance debate, it will amount to an effective ban because no manufacturer or importer will take a step down that path. So, in my view, both amendments ought to be opposed because, even though proposed with goodwill, they amount to a continuation of what has been an effective ban. I think the bill in this place should pass, unamended. I know that members are seriously considering how they are going to vote.

I would like to make some comments about what I think should not be part of this debate. Those comments relate to the role of the minister for health. There has been some commentary in the media—and indeed by the minister for health himself—that in some ways this debate relates to his values and his faith; his very publicly known Catholicism. Those things have played no role in how I have made up my mind on how I am going to vote on this private member’s bill. I do not share the minister’s faith, but I respect it. Indeed, I respect very strongly anybody who can cleave so strongly to faith in the modern age. I think that is a very admirable personal quality. This is not about the minister’s faith. It would not matter whether the current minister were minister for health, whether I were minister for health, whether some other person in this parliament were minister for health or indeed whether some person who is yet to enter this parliament were minister for health—the same policy considerations I have outlined would continue to apply.

What I do say to the minister for health is that I have been concerned not by his faith but by how he has dealt with this debate. This is a debate we should deal with in the least inflammatory way, and not in the most inflammatory way. I do not think it is appropriate in that regard to misstate the number of abortions there are in Australia and to do that consistently. The minister for health consistently uses the figure of 100,000 abortions per year.

Tony Abbott (Warringah, Liberal Party, Leader of the House) Share this | Link to this | Hansard source

Up to 100,000 abortions.

Julia Gillard (Lalor, Australian Labor Party, Shadow Minister for Health and Manager of Opposition Business in the House) Share this | Link to this | Hansard source

Even on the ‘up to’ figure which the minister interjects that he uses, he would know from departmental advice he has received that the department’s best estimate is somewhere between 73,000 and the 91,000 he mentions from the table. This is not a debate where someone should round up. Statistics can be so important. This is a debate where accuracy should be striven for. The minister is in a better position to be accurate, given the range of expert departmental advice available to him.

It is not a debate in which one should use terminology like ‘an epidemic of abortions’, ‘backyard miscarriages’ and ‘pop and forget pill’. I do not think any of those terms have any place in this debate. There is not one woman in this country who would view the decision to have an abortion as being a matter of taking a ‘pop and forget pill’. I would certainly want to believe that there is not one doctor in this country who would prescribe RU486 and then let a woman go into dangerous circumstances. If there are large numbers of such unscrupulous doctors in this country, then shouldn’t we be desperately worried and acting today on what they may be doing with dangerous pain-killing medication, dangerous cancer medication and the like? We can overwhelmingly trust our medical professionals because overwhelmingly they have proven they should be trusted. That is why the argument about backyard miscarriages should not be entered into.

Thank you, Mr Speaker, for the opportunity to speak in this debate. As I have made clear, I will certainly be supporting the legislation. The senators who are in the gallery here today are certainly in a position to tell us that senators managed to conduct this debate in a very civilised way overall and had an exchange of views about this very important issue. I look forward to a debate in this House in that spirit.

Jackie Kelly (Lindsay, Liberal Party) Share this | Link to this | Hansard source

Last week when the Prime Minister was asked for his views on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 he said:

I think there are a number of issues that have to be considered, not only the medical implications of it but also the principle that important decisions affecting the community should be made by people who are directly accountable to the community.

The Prime Minister went on:

I’ve never been one, incidentally, who believes it makes much sense to devote an enormous amount of time and energy and commitment of one’s life to win election to parliament, and to the high office of decision-making, and then to spend the next stage of life busily handing over decisions to people who are not accountable.

I agree with the Prime Minister. I did not become a member of parliament because I thought the business of government is a spectator sport. The Prime Minister also said that RU486 was not an ordinary drug. That was why it was not automatically under the control of the Therapeutic Goods Authority, like other medicines. The Prime Minister said:

Self evidently this is not an ordinary drug. You don’t have a question at a news conference involving the Prime Minister of Australia and the Prime Minister of another country about a flu tablet.

Again, I agree with the Prime Minister. RU486 is different. It involves social issues and policy matters as well as technical issues, and it involves taking into account community standards.

As others have said, this is not a debate about abortion. It is about the approval of a particular class of drugs. The Prime Minister is not the only person who thinks that RU486 is not an ordinary drug. Back in 1996, when both houses of parliament passed the bill establishing the current regime, then Labor Senator Belinda Neal said:

These issues need to be addressed by the executive of this government ... with absolute and direct accountability ...

Then Greens Senator Christabel Chamarette said:

We deserve to have a voice on issues and not simply leave them to boards of experts.

One of the problems with this bill is that it does not address the call for greater transparency and accountability. All it does is substitute the TGA for the minister and leave the process as opaque as it is currently. Another problem is that the bill has generated a debate in which we are being called upon to choose between the minister and the TGA. In my view, this is an artificial choice that we do not need to make. There is a need to involve both the minister and the TGA.

The TGA has an important part to play in the approval process. It is an expert body and the most appropriate body to deal with health, safety and efficacy issues. But these are not the only issues involved in a decision about approving the use of this drug. The use of this drug involves policy issues and social considerations, and these issues are the responsibility of elected representatives and not unelected bodies. As Belinda Neal said, there is a role for the executive of the government. It is not the responsibility of the TGA to determine social and policy issues or to assess community attitudes. This is the role of elected politicians answerable to the people. Nor is it appropriate or practical for issues to be first considered by way of a disallowance motion, particularly a disallowance motion after the decision has already been made.

However, I do agree that the minister should not be the final judge of these issues. There should be a transparent process in which the minister is accountable for his or her decision. That accountability includes making available the TGA’s assessment of an application and the minister’s decision. Such a process would ensure that a minister would not disregard advice that he or she received without very good reason to do so. In such a case, there should be a means of reviewing the minister’s decision since these issues involve matters of judgment—and none of us gets it right all the time. It is our role to review the decisions of ministers—that is the role of elected parliamentarians.

Consequently, I am moving a principled amendment which sets out these matters. This procedure will facilitate debate about detailed amendments to give effect to these principles. I believe the process for approving drugs such as RU486 should be as follows: applications for approval of the drug are sent to the minister; the minister refers the application to the TGA for its assessment; upon receipt of the assessment, the minister makes a decision, giving reasons, and publishes it; the minister attaches the TGA’s assessment to the decision; and the decision, whether it be positive or negative, together with the TGA’s assessment, becomes a disallowable instrument which can be disallowed by either House.

I believe that these principles would give us the best practical system. It is a compromise between those who say that the existing system has not been tested and should not be fixed until we know it is broken and those who say that RU486 should be subjected to the same regime as any other drug. It also enables the parliament to discharge its responsibilities to the community by either affirming or rejecting the minister’s decision should members of parliament wish to call it into question. Because a number of issues relating to approving RU486 involve matters of judgment, it is appropriate that there should be this capacity to review the minister’s decision. It is our role as elected representatives to undertake that review.

Of course governments and parliamentarians must consult and consider carefully the assessments and views of experts in their fields of competence. Still, the community expects governments and parliaments to determine policy and weigh the variety of issues relevant to important decisions. The issue before us is to decide upon an approval process. The current system is flawed, but the system proposed by this bill does not address the flaws and even makes matters worse by removing elected representatives from the decision-making process.

I am proposing a regime which incorporates the principle that the views of experts must be known and heard and the principle that it is the role of elected representatives to make final decisions which involve social and policy issues and to take responsibility for them. It also represents a fair compromise between those who believe the current system is not flawed and those who want a transparent process which involves experts in the decision-making process and in which the various participants in that process are accountable. I commend these views to the House and move:

That all words after “That” be omitted with a view to substituting the following words: “ the House is of the opinion that the bill is unacceptable in its current form and the preferred policy approach should be:

(1)

the Minister for Health and Ageing continuing to have the decision making role in relation to the approval of restricted goods as defined in the Therapeutic Goods Act 1989;

(2)

the Minister being required to obtain written advice from the Therapeutic Goods Administration prior to giving written approval or refusal to approve; and

(3)

the Minister’s decision being subject to disallowance by each House of Parliament”.

Bob McMullan (Fraser, Australian Labor Party) Share this | Link to this | Hansard source

Is the amendment seconded?

De-Anne Kelly (Dawson, National Party, Parliamentary Secretary Trade) Share this | Link to this | Hansard source

I second the amendment and reserve my right to speak.

Bob McMullan (Fraser, Australian Labor Party) Share this | Link to this | Hansard source

Before I call the member for Sydney, after consultation with the Clerk, I draw the attention of the House to the fact that this amendment is perfectly in order, but it is an unorthodox second reading amendment. I draw the attention of the House to page 361 of House of Representatives Practice concerning the consequences of the passage of this amendment. I imagine that is a proper matter not for me but for the Speaker to give some advice to the House on before the vote. It does not, of course, go to the validity of the amendment, which is unquestionably in order. I am just drawing the House’s attention to that procedural point.

Tanya Plibersek (Sydney, Australian Labor Party, Shadow Minister for Childcare) Share this | Link to this | Hansard source

I want to begin my comments today on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 by congratulating the four female senators who have sponsored this bill for their courage and determination. I want to congratulate National Party Senator Fiona Nash, Liberal Senator Judith Troeth, Democrat Senator Lyn Allison, and the remarkable Senator Claire Moore, who I see here today.

The question before us today should be: should RU486 be treated differently from other drugs? The debate really should have been about whether there is a case to be made that this drug is so dangerous that it should be treated in a unique way. Unfortunately, we have drifted into a proxy debate about the morality of abortion and about whether parliamentarians have a right to inflict their views on Australian women. This is an enormous disappointment for many Australians suffering from different types of cancer, Cushing’s syndrome and so on, who have been waiting for RU486 to be approved for some of the other therapeutic uses of the drug.

The opponents of this bill have two main arguments for why RU486 should not be used in Australia. The arguments centre around the safety of the drug for the women using it and around the broader moral question of whether women should have access to abortions at all. Any drug, any surgical procedure, has risks. When the use of RU486 was first discussed in Australia, there was a great deal less evidence of its safety and efficacy than there is today. We are now able to look at evidence stretching back 15 years. More than 21 million women internationally have used the drug in more than 30 countries, including throughout Europe, the United Kingdom, the United States and New Zealand.

There have been five deaths after the use of RU486 which may or may not have been related to the use of the drug but were related to a virulent but rare infection. Clostridium sordellii is an organism found in soil and in the human gut. But there have been other deaths from infection with this same organism, including after a liver biopsy, colon disease, bowel dysfunction, a caesarean section, a prostate biopsy and an ear infection. Sadly, there have also been five deaths in women following live births.

Four of the women who died from this infection after using RU486 lived in California, and one in Canada. The jury is still out in the United States about whether the deaths were related to RU486 at all. There was also, sadly, a death early on in France, of a woman who died of heart failure after taking RU486. A woman with such a heart condition today would not be prescribed the drug.

Opponents of the drug would say that even one death, of any woman, is one death too many, and of course in a sense that is true. The logic of the argument falters, however, when you look at the comparative figures for other drugs and the figures for alternatives to RU486.  No drug is risk free. Paracetamol, aspirin, even Viagra have their risks. In 2003, 59 deaths were caused in the United States as a result of taking aspirin. In 2003 in Australia, there were 48 deaths to which paracetamol was a contributing factor; 22 of those were suicide and 26 were accidental. In the United Kingdom, there are about 150 deaths each year from paracetamol but so far there have been none from RU486, although 31,000 British women use it as an abortifacient each year.

The Therapeutic Goods Administration reported on Viagra in 2002, after it had been used in Australia for three years. The Adverse Drug Reactions Advisory Committee had received 20 reports of myocardial infarction, which included four fatalities. A recent editorial in the journal Contraception noted that Viagra had a mortality rate of five deaths per 100,000 prescriptions, which is much higher than the worst-case scenario that we have been given for RU486, which is about one death per 100,000 patients. It seems passing strange to me that men, in consultation with their doctors, can be trusted to make decisions about a drug that has a higher death rate than RU486 but women contemplating a termination cannot be trusted to make such decisions for themselves.

The safety argument also falters when you consider the alternatives to legal medical or surgical abortions. Women die from unsafe abortions. Nineteen million unsafe abortions are estimated to take place each year. Most of these are in developing nations. There are 68,000 deaths associated with these procedures. Australian women used to die in large numbers when abortion was illegal in Australia. Illegal abortions performed prior to 1971 were second in the five main causes of maternal death for Australian women. In 1965 in Australia there were 45 maternal deaths due to abortion. There are some circumstances, we know, in which a woman will do whatever it takes to terminate a pregnancy—and that has always been the case. Restricting access to surgical or medical abortions is not about women’s safety. We also know that women die in childbirth.  Fatality rates both from live births and from miscarriages are higher than for medical or surgical abortions. If safety were the real concern, we would stop giving birth.

I do not raise these figures for any frivolous reason but to point out that there are opponents of this legislation who say that RU486 has to be treated in a special way, as a special category of drug, because it is so much more dangerous than other drugs—and that is just not right. If the opponents of this legislation genuinely believe that their objections are about the safety of the drug, let them give the evidence of its danger to the Australian Drug Evaluation Committee and the Therapeutic Goods Administration—and, surely, based on that expert evidence, those bodies would not pass it.

If opposition to this legislation is not about the safety of women using a particular drug, what is it about? Unfortunately, this debate has become a proxy debate about abortion itself. I say this is unfortunate because this parliament does not have the power to amend laws affecting the legality or otherwise of abortion—the states do that. All we can do is harass women who decide to have a termination, if they so choose. We cannot make abortion illegal where it is legal; all we can do is make it more humiliating, more expensive, more difficult or later in the term of a pregnancy, after a ‘cooling off period’ and mandatory counselling and so on.

All the emotional rhetoric and dishonesty usually used in abortion debates unfortunately has been dragged out and dusted off in this debate, so I would like to set a few things straight. The first thing I want to say is that there is no such thing as ‘pro-abortion’. Everyone in this chamber is pro-life. The notion that there are some parliamentarians or some people in the community who think abortions are just great and that there should be more of them is an absolute nonsense. I believe that every Australian would be happier if there were fewer abortions because that would mean fewer women going through what is at best an uncomfortable and unpleasant experience.

People who are pro-choice are just that. We do not want to make women have more abortions; we do not want to try and convince people who are unsure whether they should terminate a pregnancy. We are pro-choice. We believe that for most women it is a terribly difficult thing to decide to terminate a pregnancy, but we respect women enough to believe they have the ability and the right to make such decisions for themselves.

Being pro-choice means giving women genuine choices. Most are making a decision that they just cannot cope with one more child—they cannot cope physically, emotionally, mentally, financially or for some other reason. They do not feel they can be a good mother to a child or to another child.  If we are genuine about giving women choices then we have to be prepared to provide the support that would make it possible for them to continue with the pregnancy if they want to—support like paid maternity leave; affordable and accessible child care; workplaces that respect the needs of working parents; and affordable housing, so they are not flogging themselves to pay the mortgage. All too often I hear people telling other people that they should have children but offering no constructive help or support when it comes to raising those kids. On the contrary, if you end up a single mother this government will hound you and traduce you, telling you that mothering is worthless and that you should get out into the workforce and make some real contribution to society.

The second great myth that has been trotted out in this debate is that giving women a choice between medical and surgical abortion will make having an abortion easy and that will increase the rate. There is absolutely no evidence of this. The countries that allow the use of RU486 have had no associated increase in abortion rates and, in some cases, rates have fallen. The notion that throwing a few obstacles in a woman’s way will make her continue with a pregnancy is just foolish. I believe that this argument is actually code for saying that women should be punished for terminating a pregnancy, that the procedure should be as nasty as possible to teach them a lesson. It is a reminder of our original sin and a punishment for having had sex with anything but procreation in mind. It is like the old days when women were denied pain relief during childbirth because it was thought that it was good for us morally to suffer.

An associated myth is that, if we make abortions more difficult to obtain, we will decrease the abortion rate. I think that there are two ways to decrease the abortion rate: reduce unwanted pregnancies and reduce the pressure of having kids. The Netherlands has the lowest abortion rate recorded worldwide. But, since November 1984, women in the Netherlands have been able to obtain abortions free of charge under the government sponsored national health insurance system. They teach their young people to use the ‘double Dutch’ method of contraception—condoms and contraceptive pills at the same time—and have contraception readily available. They have open and extensive sex education classes starting early in a child’s life. They have extremely low teen pregnancy rates. If the Australian government wants to lower abortion rates it should support better sex education in schools, including frank discussion about contraceptive options and also a focus on teenagers’ self-esteem so they can resist pressure to have unwanted or unsafe sex.

The fourth argument being used is that the ‘experts’ are unaccountable and, conversely, only politicians are accountable. Politicians are generally accountable—I agree—but politicians can also be subject to electoral pressures. Of course, the greater objection to parliamentarians deciding the fate of this or any other medicine is that we just do not have the necessary technical knowledge. We could—and should—spend our lives reading the medical evidence for safety and efficacy. I already have a job: it is representing the people of the electorate of Sydney in the federal parliament. If I wanted to spend my life reviewing medical literature, I would have chosen another field of endeavour. I also find it extraordinary that the Minister for Health and Ageing, the man leading the charge on giving parliament the responsibility for making a complex decision about the efficacy and safety of RU486, is the same man who said we could not be trusted to decide who should be our next head of state.

The fifth area which needs clearing up in this debate is the notion that this is the Catholics against the world. Frankly, I thought Senator Nettle’s T-shirt was a juvenile stunt that put Tony Abbott right where he wanted to be—that is, at the centre of the debate. I do not believe in promoting the health minister that way, and I do not believe in insulting Australian Catholics. Although the official position of the Catholic Church in Australia is clearly opposed to the use of RU486 and to any other method of procuring an abortion, I would say that the Catholics in this place, as well as other people of faith, and people of faith in the community do not have a homogenous view on this legislation. I know plenty of Catholics who say they might not have an abortion themselves but that they do not believe their view should determine public policy. There are many people of faith in this place who feel the same way, and they have every right to their views and I respect their views. I do not think we progress the argument at all by making this a sectarian attack or by insulting people of good faith with genuinely held beliefs.

Finally, I want to canvass another argument that is used by antichoice campaigners—that is, the argument that women who have abortions suffer trauma as a result. This is a variation on the ‘it is all about women’s health’ argument, which I mentioned earlier. Sadness, a sense of loss and feelings of grief are natural for some women after a termination. Some women even suffer depression. Some women who have beautiful, much wanted, living children suffer from antenatal and post-natal depression or even post-partum psychosis. So do some women who give up for adoption the babies they carried in utero for nine months. A sense of loss or grief which some women feel after terminating a pregnancy does not mean the woman believes she made the wrong decision. Sometimes hard decisions, even sad decisions, are still right decisions. For most women, though, there is no question about the right decision for them. Nearly all of the women surveyed in a recently published Swedish study described their abortion as a relief.

In the end, although I feel that this debate should simply have been about whether RU486 is so much more dangerous than other drugs as to require a separate approval process to deal with it, the debate has in fact widened. I think some of the comments of members and senators opposed to the private member’s bill point to their real agenda. Comments such as Barnaby Joyce’s in Melbourne comparing a pregnant woman with a pram and Danna Vale’s exhortations yesterday to populate or perish show there are still people who believe a woman’s role in life is to be a vessel to carry the next generation of men—that is, that we have no right to make decisions about when we have children, how many children we have, with whom we have them and in what circumstances. These are not easy decisions. Much as we like to fool ourselves, we do not control our fertility. We can get pregnant accidentally, we can miscarry spontaneously, we can try but not conceive, we can lose the love of our lives without ever having had a child or we can seek but never find the mate we want to share the experience of parenting with. Life is uncertain and sometimes dangerous. Having children is a wonderful gift, but I think that all children deserve to be wanted and welcomed.

Andrew Laming (Bowman, Liberal Party) Share this | Link to this | Hansard source

What will probably be many hours of debate on a drug that has been debated for many years may seem somewhat tiresome to many, but I hope that we do persevere in what will be a day of very important contributions. For those contributions to be made, I do hope that we do not resort to listing the grievances of both sides of what has been a terribly vexing and at times poisonous debate. We need to remind ourselves that today we are debating the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 and that effectively, if we can possibly hold the debate to it, we are discussing whether RU486 should run through a ministerial approval process, whether it should be restricted to the TGA for consideration or whether there is another option—that is, the route of either of the two amendments that have been put to this chamber today.

I am disappointed somewhat in the contribution of the member for Sydney. For a senior member of the opposition to effectively list grievances of one side of an abortion debate I really do not feel is a terribly valuable contribution, and I would have hoped that we could have focused a little more on how we are going to handle difficult and challenging pharmaceuticals of the future. With any long awaited change, and there has been a decade of expectation since the 1996 laws were introduced, there is always the risk of an overcorrection. My concern, and that of a number of other colleagues, is that a truly complex pharmaceutical—that is, complex in its use and in its ethical and moral implications—does deserve consideration of more than purely safety and efficacy. This is not a debate about safety or about not trusting the figures. The FDA has looked at this drug expansively and the Cochrane Collaboration has examined the use of this drug expansively, so we have different verification. The debate today on this private member’s bill should be: does that evidence go exclusively to the TGA for consideration?

The TGA is a fine organisation. For anyone who has visited that institution, it is a place full of dedicated scientists who are considering the evidence of the day—that is, scientific evidence, evidence that is available to them. But I put to this chamber that, with some truly complex and challenging pharmaceuticals, we will need consideration of a whole lot more than just safety and efficacy. You would have to have lived under a rock for the last decade to think that debate over pharmaceuticals like RU486 is about only safety and efficacy. If anything, this country has suffered because there has not been informed debate because that safety and efficacy data has not been available, having not been prepared by our own TGA.

My concern is that this valuable organisation is but a unit of the Department of Health and Ageing. When an application comes for listing on the therapeutic goods register, it is ticked off not by the parliament or the minister but by the secretary of the department of health or the secretary’s delegate. So far removed is that TGA process from the concerns and the beliefs of the community that I stand here with a number of other colleagues and put this simple question: should we have one additional level of scrutiny after a body that is explicitly targeted at looking and safety and efficacy?

If one looks at the Therapeutic Goods Act 1989 one will see that there are a few circumstances in which the secretary can refuse to sign off on a TGA approval. There are about 12 of them. They are incredible pieces of minutiae. Let me just say that in history I do not believe that the secretary has ever turned down a recommendation. There have been some controversial drugs that have come before the TGA, but nothing like RU486. Some of the reasons why a secretary can turn the recommendation down are if a drug is deemed not eligible or if the secretary deems the evidence to indicate that it is not safe, it is not packaged appropriately, it has been imported improperly, it contains some restricted good, some part of its manufacture has been overseas or the listed manufacturer is not in fact the manufacturer. We do not have any means whereby any other input—social, community, anything: not even parliamentary or ministerial pressure—can be brought to bear on a secretary to have any other view.

For a great body of pharmaceuticals, that is entirely appropriate. I have no problem with that. But I make the point—and I appreciate the member for Lalor paying some attention to the details of my amendment—that the amendment that I propose today is not about drugs other than the eight drugs in this class of abortifacients. I merely make the point to the member for Lalor and to others that the TGA is about to be confronted by enormously challenging pharmaceuticals in the future and that to rely on the TGA alone, I think, will be found deficient.

In time, I believe that we will be grateful if we amend this bill today and amend the act in the near future to deal with some of the following: gene technology; biopharma, where pharmaceuticals are actually grown within plants and foodstuffs; and situations where pharmacogenetics allow us to develop drugs that are targeted to people of a unique or particular genetic profile. I can even extend the analogy to embryonic stem cell research, therapeutic cloning or euthanasia. While not exactly the same as RU486, these are areas where we have allowed legislative and parliamentary debate, community discourse and, in many cases, the willingness to vote, be it a conscience vote or otherwise. These pharmaceuticals will raise equivalent ethical concerns, if not greater ones at times. They should be afforded similar scrutiny over and above that which the TGA can offer.

My belief is that for these categories—and many of the categories are yet to be defined—we will need another level of scrutiny post science. I speak as a person of science—not a terribly bright one, but one who was trained in the scientific model, doing a scientific degree. Even I find myself saying that I could not ever hope to make the complete decision with science alone.

The opposing view, of course, is that the woman or the individual being treated should be able to discuss any kind of pharmaceutical with their carer or clinician. My view is that if we pass this private member’s bill today and the TGA is the ultimate arbiter, it is not that far off that, if some eastern European medical scientist or Korean researcher with a wonderful idea can produce a pharmaceutical that is safe and effective, it will be on Australian shelves. They think it up, and then every individual Australian must think it through. I do not patronise the individual to say that they cannot think through complex ethical and moral dilemmas if presented with the information. I merely say that, in many other areas of policy, we actually do allow some higher level of analysis, and at times legislation and a vote.

I may be naive. I may be new here. I may have an overly optimistic belief that this chamber can somehow coalesce the views of a broad community and come to some sort of solution—not a perfect one. But I would like to see that debate come here in situations where we are quite aware that this is an extremely sensitised debate.

The criticism of the position of bringing it back to parliament is that the TGA are eminently capable. They are for safety, efficacy, quality and availability. That is what they specialise in. But they go no further. I stand to be corrected, but if you wanted to talk about morality and the ethical implications of pharmaceuticals with the TGA, you would find yourself in the legal unit. That is probably as close as you would get to having those discussions. It is not a body designed for that role. Some will say that parliament has no role for this form of decision making, but I put to you that this class of drugs sits with a number of highly contentious issues that deserve at least one more level of scrutiny.

An interesting claim has been made that there will be a lack of certainty for an applicant who may bring a drug like RU486 into the TGA process—convoluted and expensive as it is—only to see it fail at the last minute here in parliament. All indications here are, first of all, that this is not being brought by some multibillion dollar company. That IP has been handed over long ago. There are not rows and rows of people stacking up to approve drugs in this category. There is one drug, RU486—well known, used in scores of countries—that will be brought to the TGA and, with FDA information and analysis, will have a reasonable chance of getting through the TGA. Certainly we ourselves will have evidence that the passage of that drug is quite possible through the parliament. That evidence will come from the votes tomorrow and come from the Senate vote that has already taken place.

I want to clarify that using a solution like a disallowable instrument will not result in multiple applications to this place. A disallowable instrument is something that is frequently applied in this parliament. It is often used. It works very well with excises. It is one with which we are all familiar. It gives a chance for parliament to challenge a regulation or a decision by a scientific body. I think that is a perfectly reasonable way of approaching this challenge.

But here we have a dilemma. The TGA process might be often used and might be quick, but, given the time it takes to get through the TGA, an additional two or three weeks in the parliament is relatively insignificant. But, once the TGA process is knocked over by a disallowable instrument, you really cannot launch more vexatious applications for the sake of it. Certainly within the TGA act there is a chance, through the special access scheme, to bring in small amounts for, say, research purposes. But that would not be subject to a disallowable instrument; that would be an application to the TGA separately to say, ‘We would like to use this medication for research.’ It would have to jump certain bars. It is highly unlikely that a well-established and long used overseas drug like RU486 would suddenly find research applications in Australia.

One application could go right through to a disallowable instrument and either be knocked over or otherwise, but you would not see generic versions of RU486 or multiple private sector organisations pushing similar products. It is one product. It is RU486. There have been no subsequent versions of this pharmaceutical. There are no other competing first-to-market arrangements here; it is one tired old pharmaceutical that has been around for 15 years. It will either get up or it will not. Yes, after TGA consideration, it will come back here one more time for a vote. But I think it is a tremendous insurance to know that the community views come here for that ultimate vote and it is likely to be once and only once, unless of course there are new pharmaceuticals of a similar character.

I think Australians will be very relieved to know that such an option remains for them if, say, a more advanced version of RU486 were to be developed—say a second trimester abortifacient. ‘Oh, it is safe. It is effective. The drug is of fine quality,’ says the TGA. What then? The secretary of health signs off on it and that is it. What are we going to do if we have that situation? Will we turn around and write new legislation trying to block a single drug? It is very wise now to have the insurance of such a disallowable instrument from this amendment today.

Of course the risk we have is that many will be quietly coveting the opportunity to come to the parliament and knock over RU486 with a vote. My view is that we should not see that as being some means to obstruct a new pharmaceutical; it is an opportunity for the wide sentiment in the community to find their way here and ultimately to be voted upon. If there were a higher body, I think as a doctor I would be prepared to say I would like to know what the higher body would think. But if this is where a vote has to happen, then I think we have to be prepared to let that decision be made. After all, we are paid to make tough decisions and we do so quite regularly.

Today will be a torturous day for many. It will be a hard debate. It will not be as hard for me as it was as a clinician doing 10 surgical terminations of pregnancy in the morning and then counselling women in the afternoon about infertility, and the awful period that I had in between the two sessions trying to resolve and understand precisely what I was doing in my job. With a medical background, I can never pretend to have walked in the shoes of someone who has had to make a choice between surgical or medical termination or nothing at all.

I do not for a moment stand up here and say that I have a view on a drug going through or otherwise. I do believe that if the amendments are defeated in this House in the next 24 hours I will still support the bill to ensure that those options are available to women. But I am unable to convince myself that completely leaving these decisions to the TGA is the right thing to do. For those reasons, I believe the amendment that I have proposed, with a disallowable instrument in parliament where there is disagreement with the findings of the TGA, is a reasonably elegant solution to what is otherwise an insoluble problem.

Bob McMullan (Fraser, Australian Labor Party) Share this | Link to this | Hansard source

Before I call on the Deputy Leader of the Opposition, I just want to clarify something. Although the member for Bowman has talked about the amendment he has proposed, he is actually not moving it now. You are proposing to do so in the consideration in detail stage?

Andrew Laming (Bowman, Liberal Party) Share this | Link to this | Hansard source

Yes.

Ian Causley (Page, Deputy-Speaker) Share this | Link to this | Hansard source

Thank you for that. I did understand that.

Jenny Macklin (Jagajaga, Australian Labor Party, Deputy Leader of the Opposition) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 removes the restricted goods category from the Therapeutic Goods Act and in so doing places the onus of determining the safety and effectiveness of RU486 and similar drugs into the hands of the Therapeutic Goods Administration. This bill does not require us to make a decision about the rights or wrongs of the use of RU486 for abortions in Australia. Nor does it force it. This bill is not about abdicating responsibility that elected representatives should exercise. Ethical decisions should be made by parliament, but, in the case of abortion, those decisions were made decades ago by state parliaments. At the federal level Medicare helps pay the cost of a surgical abortion. That decision too was made some time ago. Let us be clear: this bill fixes an anomaly where RU486 and similar drugs are the only drugs in this country that are to be approved or not by the minister for health rather than the TGA.

The question before us is this: is the TGA competent and capable to rule on the safe and effective use of RU486 for Australian women? The answer for me is an unequivocal yes. If it were no, it should be of grave concern, given the drugs approved for use in Australia by the TGA. The TGA has overseen the approval of nearly 50,000 drugs, many of which are dangerous and have serious side effects. The TGA is independent and operates on the basis of expert assessment and constant review. The TGA’s decisions cannot be amended or challenged by the sponsors of drugs or by parliamentarians.

So even though all that this bill does is correct that anomaly, the debate surrounding this bill has become one of: should women have access to medical abortion or not?  My view is that women should have control over our reproductive lives. The reproductive experience is a difficult one. Contraception, pregnancy, miscarriage, termination and difficult births are all part of our reproductive reality over about 40 years. Women have to treat these possibilities seriously, and we do. Decisions about control over our fertility are first and foremost ours to make, and we take these decisions very seriously.

Over the ages abortion has been a serious issue for women, because our fertility is not fully controllable. Women understand the need for access to reliable contraception, but the reality is that no contraceptive method is foolproof. Every woman’s body is different and reacts differently to contraception. It is because our fertility is not fully controllable that safe and legal options for abortion are necessary and should be accessible to those women who want to choose them.

Women are also the main nurturers and carers of children. Of course we understand the implications of terminating a pregnancy, and it is no wonder that this issue provokes such gut-wrenching emotion or deep-seated feeling. We women can and do deal with these hard questions, but we need safe choices. The need for safe choices in difficult situations and the belief that a woman and her doctor are perfectly capable of making decisions about termination of pregnancy guide my view.

My own thinking on abortion has altered over the years. I find it a very complex issue on a range of emotional and personal fronts, but I continue to believe that women must always have the choice of terminating a pregnancy safely. I do not know any woman who would find abortion an easy choice; it is always a difficult and emotional decision. But the decision to have an abortion is not made any easier by the fact that our society expects women to be silent about their experiences, their pain and their anxiety. The public reaction to Senator Lyn Allison is proof that the personal experiences of one in three Australian women are almost never part of the moral or political debate, so we have a very long way to go before we stop demonising individual women and start supporting them in their difficult choices.

Of course we need better education to prevent unwanted pregnancies, and more support for women if they are making a decision that might be to terminate their pregnancy. No-one concerned with basic human wellbeing would call themselves pro abortion or anti life. Nobody I know says that there should be more abortions. Nobody I know wants to see more women going through the turmoil that terminating a pregnancy can involve. But the key to reducing abortions is reducing unwanted pregnancies, not restricting access to safe and legal abortions. Restricting access to safe and legal abortions means one thing: women die. It is a simple fact, a fact that unfortunately still has such a serious impact on so many women throughout the world.

Accessibility is crucial, and that means abortions must not just be legal but be available, affordable and safe for all women. In many countries RU486 is an alternative for women who cannot or do not want to go through a surgical procedure. It is also an alternative that doctors can offer women in regional areas who do not have access to surgical abortions. It disappoints me that some people think that RU486 could lead to more abortions in Australia. I am appalled by the health minister’s argument that if RU486 is licensed we could see a spate of backyard miscarriages. No-one supporting this bill wants to see women taking RU486 without medical supervision. Throwing around words like ‘backyard miscarriages’ is not only misleading but inflammatory and manipulative, and the health minister should not play around with people’s emotions in that way.

Tony Abbott (Warringah, Liberal Party, Leader of the House) Share this | Link to this | Hansard source

So where would these miscarriages take place?

Jenny Macklin (Jagajaga, Australian Labor Party, Deputy Leader of the Opposition) Share this | Link to this | Hansard source

Obviously the minister for health continues to want to throw these allegations around. As a woman I cannot even begin to comprehend why a woman would go around taking RU486 in an irresponsible way, and it only seems to be the case that the minister for health has that view. Studies in France, England, Wales and Sweden show that there was no increase in the incidence of abortions at all when RU486 was legalised. As for miscarriages, in about five per cent of cases where women have taken RU486, a minor surgical procedure is needed to complete the abortion. This is also the case with natural miscarriages.

RU486 is an alternative to a surgical procedure for the termination of pregnancy. It offers women a choice over how they undergo an abortion, not whether or not they have an abortion. Those who suggest that more women would be willing to have an abortion if it involved a pill should listen to women’s experiences first. Abortion has been a social reality for thousands of years, whether it is safe or unsafe. It is not something that hangs on the difference between taking a pill and having a surgical procedure. Approval of RU486 is not an advertisement for abortion, nor should it ever be portrayed as an inducement for abortion. The safety of RU486 or a higher incidence of abortions should never be code for questioning women’s access to safe surgical or medical abortions. The parliament has no role in meddling in decisions over which method a woman can use to terminate her pregnancy—that is for her and her doctor to decide together.

Finally, I want to emphasise that of course the Therapeutic Goods Administration is an accountable institution. Its board has ministerial appointees; it is governed by a rigorous act and a vast set of regulations. The TGA’s decisions are transparent and based on expert evaluation of evidence. The TGA also insists on continuous monitoring of new evidence, even after a licence has been granted. We, as members of the public, can hold the TGA to account through the Administrative Decisions (Judicial Review) Act. It is certainly not the case that the TGA is some renegade fly-by-night operation.

If opposition to this bill is about lack of confidence in the TGA, then it is the parliament’s task to address those concerns. But the fact is that no-one is questioning its professionalism. If the TGA retains this parliament’s confidence then the TGA is competent to make a ruling on the safety, efficacy and conditions for use of RU486—just like it does for all other drugs. For these reasons I will also be opposing the amendments moved to this bill. The decision on the safety and efficacy of RU486 is for expert scientists based on evidence and safety.

Finally, I must make it clear that this bill is not about a vote of confidence in the health minister personally or in his government. If this bill is seen to be a personal vote of confidence in the health minister, he has no-one but himself to blame. The health minister’s actions alone have personalised this bill. A vote like this should not be an invitation for ministerial arm-twisting and cajoling, including on the spurious basis that a contrary vote would be a vote of no-confidence in either the minister or the entire government. So let us not have the minister for health distracting any further from the crux of this issue. The bill is about treating RU486 the same way that we treat every other drug in this country. Can I leave it up to experts to determine the safety and efficacy of RU486? And if they decide it is safe, can I leave it up to women and their doctors to decide the best way to terminate a pregnancy? My answer is yes. For me, they are the places where these decisions should belong.

Sophie Mirabella (Indi, Liberal Party) Share this | Link to this | Hansard source

I want to thank the Prime Minister for giving members of the House a conscience vote on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. As we all know, ‘free’ votes are rare in the Australian parliament, and we as parliamentarians are bound not by party votes or practices but by our individual consciences. I welcome this aspect of the debate on the bill.

But before we embark on further debate on what has already been something of a rhetorical minefield of loaded language it is important to put some things on the record in this place. This is not a debate about the religious practices of the Minister for Health and Ageing. This is not a debate about the rights of women. This is not a debate about the rights of embryos. This is not a debate about men telling women what they should do. This is a debate on a clumsy bill, foisted on the parliament by four women with well-meaning but essentially misguided motives.

I want to place on record that I support the current arrangements that exist in state and federal law regarding abortion. We know that, in Australia, the legislation pertaining to abortion and pregnancy termination is not an Australian government matter but the responsibility of state governments. Each jurisdiction has different legislation, adding to the complexity of this matter.

The substance of this bill is simple, but its effects would be far-reaching. In some ways, the bill is nothing more than a ruse, clearly muddying the waters of sophisticated discussion on an important ethical and medical issue. The question must be raised as to why we did not have this debate when Mr Wooldridge was minister for health. Why did we not have this debate when Senator Patterson was minister for health? And, indeed, why did we not have this debate when the member for Fremantle precariously held the health portfolio?

The member for Lalor was at pains last week to say, ‘This debate is not about Tony.’ She and other members of the Labor Party and the feminist sisterhood have done a good job of making the debate about Minister Abbott in a most personal and vindictive way, which has clouded sensible debate on this issue. The member for Lalor seems obsessed with the religious beliefs of the minister for health, as are many others. The female sisterhood of the Labor Party is at it again: they criticise the minister for health for his Catholicism and his views on abortion—which, incidentally, are not exclusively Catholic views—and then wonder why the growing number of the religious right will not vote for them.

One thing I find personally intolerable is revisionist history, and for this reason it is important to look at the legislative background that gives rise to debate on this bill. Back in 1996, the amendment that gave the minister for health discretion in approving the importation and use of RU486 and other abortifacient drugs was supported by every political party. When the 1996 act was amended, abortifacient drugs, of which RU486 is one, were classified as restricted drugs and required the consent of the minister for health before their importation into Australia. There is nothing particularly controversial about that. It was, after all, something that received bipartisan support in this place. Even the Greens, believe it or not, supported the amendment.

The Greens senators in the other chamber might recount the words of one of their own, Senator Chamarette, when she claimed back in 1996 of members of parliament and senators:

We deserve to have parliamentary scrutiny of decisions ... and not simply leave them to boards of experts.

There were no T-shirts with the words ‘Mr Abbott, get your rosaries off our ovaries’ back then, as one particularly silly and juvenile Greens senator proudly displayed last week.

For those who want to make the point that RU486 should be assessed by the TGA, as is the case with thousands of other drugs, the 1996 legislation gives the answer. RU486 falls into a different category of drug as its purpose does not fit into the legislative proscription of a therapeutic good.

The 1996 debate on ministerial control of RU486 only occurred because in 1994 a very junior official in the department of health ingenuously decided to approve the importation of RU486 without the knowledge or consent of the minister for health, and then proceed with trials of the drug by Family Planning Victoria, which were then suspended by the then minister, Dr Lawrence—a Labor minister—because the organisation had not properly informed women of the drug’s health risks and side effects. Indeed, there are significant health risks that I shall comment on a little later.

The current restrictions are necessary and should remain in place. Regrettably, the bill takes away the power of the executive and gives it to the bureaucrats. Symbolically, this bill represents perhaps the greatest dispersal of power in this country in the last 30 years. What sort of trend does that set for the future decisions of this parliament? Are our ministers and elected representatives bereft of making decisions that affect the Australian people? Why should we as legislators, and the minister for health in particular, let the faceless, unaccountable, undemocratic and unelected cabal at the Therapeutic Goods Administration supplant our role as accountable, elected and responsible representatives of the people?

As the great George Burton Adams said when writing on the 1626 trial of the Duke of Buckingham:

The modern doctrine of ministerial responsibility can hardly be more fully stated ... The minister is responsible and must be held accountable.

I for one have every faith in the minister to do the right thing by the government’s standards. How effective can the Therapeutic Goods Administration be in deciding the merits of a drug that, by the current legislative standards of the 1996 amendment, is clearly not ‘therapeutic’?

The most assiduous promoters of the drug state the overseas experience that the drug is widely available in the US. I wonder whether these advocates have actually read the disclaimers in the US that women have to sign before they clock up treatment for a chemically induced abortion through RU486. I count myself as one of the few Australian parliamentarians—perhaps the only one—to have received comprehensive briefings on the safety and efficacy of RU486 by the pro-life movement, the pro-choice movement and the independent authority, the American Food and Drug Administration. This was an invaluable opportunity in the formation of my own conscience on this matter to hear the pros and cons of both sides of this argument.

The story was not all rosy. The American Food and Drug Administration is aware of the deaths linked to RU486 use—so aware that it is establishing an inquiry into the safety of RU486. Since its approval of RU486 in 2000, significant safety concerns have arisen. In July 2005, the FDA issued a public health advisory on RU486 and said that there had been four documented cases of death from infection in little over 18 months following medical abortion with RU486. I have seen the briefs of the complainants in the cases against Danco Laboratories—which is the US distributor of RU486—that were filed by the families of two young women who recently died in California as a result of using RU486.

The promotional material makes it sound so easy: a ‘safe and effective’, ‘nonsurgical’ method of termination, but the reality is quite different. After the initial dose of RU486, the patient then needs to take a second drug—a prostaglandin Cytotec or misoprostol—which causes the uterine contractions that expel the embryo. Curiously, the experience has been that RU486 has neither significantly increased the number of abortions nor increased its availability in rural and remote areas. Yet, over time, it essentially substitutes surgical terminations with a chemically induced procedure. This raises the prospect of whether we should be encouraging rural women down this path fraught with the possible medical dangers without the likelihood of appropriate medical superintendence.

With rural obstetricians in something of a decline, midwifery units in short supply in rural and regional areas and the difficulties associated with doctor shortages in some areas of rural and regional Australia, replacing a surgical termination with a chemically induced one, and then not having the associated medical expertise to administer it, worries me deeply. The fact is that the level of medical assistance and supervision needed after a chemically induced abortion—for example, via RU486—is even greater than that of a surgical termination.

We know from the research undertaken by the Parliamentary Library that ‘medical abortion, like surgical abortion, requires the availability of an appropriate level of back-up medical care to address possible complications arising from the procedure’. Up to eight per cent of the cases will not result in a successful termination. There have been numerous cases of the foetus failing to expel from the uterus. Rural women will require instant medical assistance in the case of the ensuing internal bleeding, cramping, infection, haemorrhaging, abdominal pain, pelvic pain, septic shock or ruptured ectopic pregnancy that can commonly occur with RU486. In other words, where RU486 is used, the medical practitioner must be able to perform an emergency surgical abortion or have ready access to surgical abortion.

The proponents of RU486 list its ‘safety’ as its redeeming feature. This is seriously misleading as they conveniently omit statistics regarding the incidence of heavy bleeding and pain which is a direct concomitant of this form of chemically induced abortion. For instance, the New England Journal of Medicine reported trials where nine per cent of women reported bleeding after 30 days and one per cent were still bleeding after 60 days. They found:

Excessive bleeding necessitated blood transfusions in four women, and accounted for 25 to 27 hospitalizations ... 56 of 59 surgical interventions, and 22 of 49 administrations of intravenous fluid.

A Columbia University study also found that ‘20 per cent of women bled or spotted for five to six weeks’. So much for the safe alternative to surgical abortion.

The medical disclaimers for RU486 in the US clearly state that if one cannot easily get emergency medical help after taking the pill then it should not be taken. Representing a rural area myself, I am disturbed by this fact. We have also got to be a little sceptical of the fact that most of the medical literature supporting RU486 is sanctioned by the pharmaceutical industry.

This bill raises important moral and ethical issues which I feel are not best left in the hands of laboratory technicians and bureaucrats. Governments are here to govern and ministers are here to be held accountable. Those of us in this place representing rural and regional areas carry a heavy responsibility of a significant medical, ethical and social magnitude when coming to a position on this bill. I am comfortable with my decision to vote against this bill, even though in all likelihood it will pass in its current form. Some of my enthusiastic colleagues have submitted amendments. I know these are well meaning, but essentially for me they miss the point. I feel Australia is best served by retaining the current arrangements which recognise the primacy of the parliament and the role of the executive government of the day.

I will vote against this bill not under the influence of the flurry of email activity from people right across the country or the significant increase in telephone traffic to my electorate office but, rather, because the current situation has served us well and should continue. This drug will not increase access to abortion for country women, it will not make abortion safer but will increasingly substitute surgical abortion—the latter being the safer and more efficient abortion option. I for one do not wish to see my public duty as a representative supplanted on such a serious ethical and social minefield by an unelected, unrepresentative and faceless bureaucracy and will be opposing the bill.

Julia Irwin (Fowler, Australian Labor Party) Share this | Link to this | Hansard source

The debate on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 goes beyond considering a small amendment to the Therapeutic Goods Act. The principles we are debating go to the heart of democratic government and the rights of citizens. The major parties in this parliament have allowed their members a conscience vote on this issue. The decision to remove the discretion of the Minister for Health and Ageing to allow the import and registration of the abortion drug RU486 will be decided by each of the 150 members of this House, as it has been with the 76 members of the Senate.

We have an opportunity to exercise our individual conscience. We will not allow the majority view of our party rooms to dictate how we vote on this issue. We all acknowledge that our views on this issue will be determined by what we understand to be our own moral and ethical beliefs. But the 20 million or so other Australians depending on the outcome of this debate will not have the fundamental right to follow their own conscience. If we regard this issue as one which demands that members of this parliament should be free to vote according to their conscience, why then would we even consider keeping on our statute books a law which denies the right of Australian citizens to exercise their own conscience?

On the one hand, we have opponents of this bill who assert that in a democracy we must obey the moral dictates of those who are acknowledged to be moral and ethical leaders. The opponents fail to accept that ours is a pluralist society which accepts a range of standards. We are governed in accordance with accepted norms rather than so-called moral truths. Those who believe that abortion is wrong are free to hold their beliefs and, within reason, to spread those beliefs to others. But they do not have the right to impose restrictions on behaviour which is acceptable to a substantial proportion if not a majority of the population. To impose their moral beliefs on others is nothing less than tyranny. Some speakers in this debate have said and will say that it is not about abortion—that abortion under acceptable conditions is not illegal in Australia.

But this debate is very much about restricting access to abortion. In that way, it is part of an agenda being followed in many parts of the world. Unable to prohibit abortion in Australia and in other countries, the anti-abortion lobby has attempted, and in some countries succeeded, in restricting access to abortion. That is the only reason behind the original move by Senator Harradine in 1996, and that is the only reason behind the members who are opposing the bill now. Their real objection to allowing the use of RU486 is that it can make abortion more accessible and acceptable. That was the clear message in the original debate back in 1996. In the words of former Senator Lees:

While respecting Senator Harradine’s views, opinions and beliefs on this issue, I do have to make it very clear to senators that what we are voting for, if we support those amendments, is a restriction on women for the right to choose. They are restricting a woman’s choice, to require her to terminate a pregnancy only by surgical means. They will effectively take away what is now termed the morning after pill or RU486 and future generations of this pill or a similar substance.

That is precisely what happened and has been the case for the last 10 years, and the opponents of this bill will want to keep it that way. If they cannot stop abortion altogether, they want to make it so hard to access that it might as well be banned. By preventing access to an alternative to surgical abortion, opponents know that many women will not be able to travel to the hospitals and clinics where these services are available. For women in smaller regional centres as well as outer urban and not so remote locations, medical abortion is a safe alternative. While all states have set requirements for legal abortion, equality of access can be limited by allowing only surgical abortion. RU486 is a safe and effective means of abortion. It can be less expensive and reduce the demand on scarce surgery resources.

But opponents of this bill would not allow these considerations. For them, the fact that RU486 can be used in the earlier stages of a pregnancy, with fewer risks than those associated with surgical abortion, is not something they want to see. In their time-honoured tradition, they want to pile on the guilt. At the very least, they want to keep abortion as an invasive procedure with all the risks of surgery. They do not really have the interests of women at heart. They only have their own agenda, and they will stop at nothing to impose their own will on all Australian women.

It was interesting to note the greater number of women senators voting in favour of this bill, and it will be very interesting to note the number of women in this House who vote in support of the bill. While this bill would remove the Minister for Health and Ageing from the approval process, registration for use of RU486 in Australia would require the approval of the Therapeutic Goods Administration, the authority charged with the responsibility of vetting all drugs approved for use in Australia. It may also require local clinical trials before being widely available. This is the same Therapeutic Goods Administration that approved Viagra, Vioxx and Celebrex for use in Australia, all without referral to the minister of the day. But no-one in this debate is suggesting that the TGA is not a competent and objective authority to rigorously assess the risks and benefits of RU486 before any approval.

RU486 is approved for use in the United States of America, the United Kingdom and in most western European countries as well as in Russia, China, Israel and New Zealand. RU486 has been used in many of those countries for more than 10 years without raising serious concerns for its safety. The World Health Organisation has certified RU486 as safe and acceptable to women. The use of RU486 is supported by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and the Australian Medical Association. There are risks with any medical treatment, but we must also consider that around 70,000 women die each year as a result of unsafe abortions. Many thousands more are left with disease and injury as a result of unsafe abortions.

One estimate suggests that worldwide there are about 50 million abortions each year. In Australia estimates range up to 100,000 abortions each year. The question to be asked is: is that too many? Few people would suggest that abortion should be the preferred method for women to control their fertility. But we have countries that have very low birth rates, such as Japan, where abortion is legal and where, until recently, the contraceptive pill was banned. And Poland, a Roman Catholic country where abortion is banned and contraceptives are severely restricted, has one of the world’s lowest birth rates.

In Australia those who express alarm at the number of abortions are often the same people who advocate restrictions on access to sex education and contraception. They are so far out of touch with the beliefs and aspirations of Australian women. And then we get the absurd claims by the member for Hughes, who wants Australian women to join her crusade.

I will now turn to the proposed amendments to this bill. The effect of both is to single out RU486 as the only drug or class of drugs whose registration is subject to disallowance by this parliament. Again we see an agenda of restricting access to procedures which are otherwise not illegal—that is, they definitely have the same agenda as Senator Harradine did 10 years ago. The only difference is that it also places a greater risk on the drug manufacturer. Not only does the manufacturer need to seek approval from the Therapeutic Goods Administration but, having succeeded in that objective assessment, they also face the political risk of the parliament rejecting the application. It is the same old tactic: place as many obstacles as you can in the way of allowing women access to safer and cheaper abortion.

In the present political climate you have to ask whom they think they are fooling with an argument that the parliament should have the final say in government decision making. As I said at the beginning, the true conscience vote on this issue is the decision made in good conscience by a woman, on the advice of her doctor and, if she wishes, her partner and family. To say that only the parliament is qualified to make such a decision is a definite slur on Australian women.

Abortion is accepted by a significant proportion of the Australian people. Our laws must be based on the accepted norms of Australian society, not on the views of self-appointed moralists. Our conscience votes on this bill must be to allow all Australian women the right to exercise their own consciences. I will vote for this bill, and I definitely will not vote for the amendments.

Andrew Southcott (Boothby, Liberal Party) Share this | Link to this | Hansard source

In considering how to vote on the private member’s bill before us, the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005, like all members, I weighed a number of factors. The first consideration was that abortion under some circumstances is lawful in the six states and two internal territories of Australia. In Victoria, Queensland and New South Wales a common-law test is applied. In Tasmania, South Australia, Western Australia and the Northern Territory there is a detailed statutory regime which deals with the termination of pregnancy. For example, in South Australia the termination of a pregnancy is not unlawful where carried out within 28 weeks of conception in a prescribed hospital by a legally qualified medical practitioner, provided he or she is of the opinion, formed in good faith, that either the maternal health or the foetal disability ground is satisfied. Two doctors must certify this in writing and the abortion must be carried out in a hospital. That is the current law in South Australia. Each state and territory is different but has laws relating to the termination of a pregnancy which are based to an extent on common-law tests set down in judgments over 35 years ago. So the first consideration was that abortion is a lawful procedure under certain circumstances under state and territory law.

The last time the federal parliament had an extensive debate on the issue of abortion was in March 1979. The motion moved then by the Country Party member for Hume, Mr Stephen Lusher, requested that the government introduce legislation to provide that medical benefits would not be provided by the Commonwealth for the termination of a pregnancy unless the termination was performed to protect the life of the mother from a physical pathological condition. This motion was amended to read that the Commonwealth should not pay medical benefits for the termination of pregnancy unless performed in accordance with the law of a state or territory.

For almost 27 years that has more or less been the position in the federal parliament, an understanding that any changes to the abortion laws would come from the state and territory parliaments. But the federal parliament clearly does have a role in the approval, listing and monitoring of drugs. So, in considering the issue of RU486 being used as an abortifacient, the issue is who should determine whether it is safe for maternal health for this drug to be listed. My view is that, if listed for a termination of pregnancy in accordance with state or territory law, the Therapeutic Goods Administration is entirely competent to determine the safety, quality and effectiveness of this drug. There has been a lot of discussion about the risk and adverse effects of RU486. That is a matter for the TGA to determine.

The TGA makes evidence based risk assessments. If it determines that RU486 is not safe it will not be listed. If it determines that it is safe, it will be listed. The TGA’s role is to identify, assess and evaluate the risks posed by drugs and medications. RU486 would only be registered as an abortifacient if it is shown to be safe and effective for that purpose. But there are a number of fail-safes before this would occur.

The final decision in registering any therapeutic good for inclusion on the Australian Register of Therapeutic Goods rests with the Secretary of the Department of Health and Ageing or the secretary’s delegate in the TGA. This occurs after the secretary has received a resolution from the Australian Drug Evaluation Committee, an independent group of medical experts—some of them eminent medical experts—appointed by the minister. The secretary of the department then has circumscribed grounds on which refusal of any therapeutic good can be made. These grounds include: the goods are not eligible for listing, or the goods are not safe for the purposes for which they are to be used. Although no refusal to register has ever been made, that power is there for any drug, exercised by the Secretary of the Department of Health and Ageing. After this stage, the National Drugs and Poisons Schedule Committee is able to apply conditions for the prescribing of medicines. The committee consists of state and territory government members and other persons nominated by the minister, including technical experts. So I have satisfied myself that the TGA is quite able to determine if RU486 is safe for listing in Australia.

The last step that would happen is that, if a woman decided to have a medical abortion, this would be done in consultation with a doctor. The professional bodies, such as the Royal Australian College of General Practitioners and the Royal Australia and New Zealand College of Obstetricians and Gynaecologists, have developed protocols and guidelines in the use of this drug and would expect their members to prescribe it in accordance with these protocols. RU486 would only be administered by a qualified medical practitioner who would be responsible for the supervision and monitoring of their patient.

I sincerely appreciate the many representations I have received covering a wide range of views. As I have said in my speech, there are already several layers of accountability here. Firstly, the termination of a pregnancy would have to be in accordance with the law of a state or territory. Secondly, the TGA must have applied an evidence based risk assessment to RU486 using all available information and determined it to be safe and effective for the purpose for which it is intended to be listed before it is registered in Australia. Thirdly, a qualified medical practitioner must prescribe the drug and monitor their patient in accordance with protocols and guidelines developed by the professional colleges. And, lastly, the woman must give an informed consent to a medical abortion after a discussion with her doctor and a consideration of her options.

If all those conditions are met, I see no reason to oppose this private member’s bill. These free votes, and this debate in particular, are never easy but each member brings to it their own experiences and view of the world. Having weighed the issues, considered all the representations and read the report on the bill by the Senate Community Affairs Legislation Committee and other material carefully, I will be voting for the bill.

Jennie George (Throsby, Australian Labor Party, Shadow Parliamentary Secretary for Environment and Heritage) Share this | Link to this | Hansard source

We are being asked to revisit the decision made by parliament in 1996 when an amendment to the TGA Act was carried to create a new category of drugs known as restricted goods. As we know, these restrictive goods included RU486, which cannot be evaluated, registered, listed or imported without the written approval of the minister for health. All other medicines used in this country have been evaluated and regulated by the TGA without any requirement for approval by the minister. I believe the TGA has provided independent scientific advice on new medications in a very professional and impartial manner for the last 20 years.

Under the current arrangements, in my view there is not a significant level of parliamentary scrutiny in relation to RU486, despite the claims made by people in this debate. In my reading of the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 as it stands, the minister is simply required to notify the parliament of a decision to approve an application for evaluation by the TGA, but the minister is not required to table decisions to not approve such applications—meaning that the parliament is neither necessarily informed of these, nor does it have the capacity for any oversight of such decisions.

Some 10 years since that amendment was made to the act, we are being asked to revisit the decision. I, like most other politicians, have received numerous submissions from constituents both for and against the private member’s bill. Some views against the bill have been put very forcefully to me. I have taken all the views from my constituents into consideration, and I have read as much as I can to try to come to a decision that, in all conscience, would allow me to vote in a particular way. I do accept that, in arriving at my conclusion, as a local representative I am accountable to my electorate as to how I vote and the reasons for coming to my decision. It is a conscience vote that I have arrived at in good faith, and I trust that my constituents, even those that will not necessarily agree with the position I put, will treat that decision in good faith.

Having read and thought about the issue I think the fundamental question that has to be answered is this: who in my view is the appropriate authority to evaluate the risks associated with RU486 and determine its appropriateness or otherwise for authorised use in Australia? I have come to the conclusion—and I will give you the reasons in a minute—that in my view the appropriate body is the TGA, and accordingly I will be voting in support of this private member’s bill.

In coming to this position on the bill, I have tried to analyse the arguments both for and against. I have posed a number of questions that I have worked through in coming to that position. The first question is: what do we now know about the use of RU486, which has been used over the decade since the amendment was introduced in 1996? The second question is: what does the experience of the use of that drug conclude about the level of risk involved in the use of RU486? The third question is: what is my assessment, as a lay person, of the safety of the drug? The fourth question is: should medical abortion, using RU486, be allowed in Australia? Previous speakers have pointed out that abortion under certain circumstances under state and territory law is legal.

While I can come to some personal conclusions and answers to the questions I have posed, as I have thought through these issues, I believe that no politician should be the ultimate authority on these issues. We will have our personal views, but those views will not necessarily be based on expertise or a scientific basis for making those judgments. Accordingly, I believe, as previous speakers have outlined, that the TGA has been specifically charged with a responsibility that goes beyond that of individual personal views.

The TGA is specifically charged with identifying, assessing and evaluating the risks posed by therapeutic goods; applying any measures necessary for treating the risks posed; and monitoring and reviewing the risks over time. In other words, evidence based evaluation of the merits or otherwise and the risk profile of RU486 can only be undertaken by an independent body relying on scientific and medical expertise. How better to resolve the genuine concerns expressed by my constituents—and many members in the chamber—about the safety of RU486 than by referring it to the TGA for evaluation and assessment?

In my reading for this debate, what are some of the conclusions that I have personally come to and what is the knowledge that has been accumulated in the past decade, since the decision was originally made? We know that RU486 has been used over the past 10 years in about 33 to 35 countries. There is now a much greater understanding of the level of risk, as a result of clinical trials and widespread use. Some two million terminations have now occurred using RU486 in Europe and the United States. It was first licensed in France in 1988, in the UK in 1991 and in the US in 2000. Countries approving its use include France, New Zealand, Britain, Sweden, the USA, Israel, China, countries in western Europe, Turkey and Tunisia.

The International Planned Parenthood Federation’s medical advisory panel concluded that the drug is safe and effective for medical abortion and approved its use in their 151 member associations across the world. Interestingly, RU486 has been included on the World Health Organisation’s essential drug list. The WHO has declared medical abortion ‘safe, effective and acceptable if the few conditions which warrant control are identified and post-abortion care is available’. The use of RU486 is supported by the AMA here in Australia, by the UK and by the American College of Obstetricians and Gynaecologists.

The President of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists said recently:

One of its uses is in early termination of pregnancy, and there is evidence that it’s sometimes a better and safer option for women than surgical termination.

It is true that, in the submissions that I have received from constituents, concern has been expressed because there have, it appears, been five deaths attributed to RU486 in the United States and in Canada after women developed septicaemia. This occurred over a five-year period during which there were an estimated 530,000 medical abortions using the drug. According to people with more expertise than me—and I quote from Dr Weisberg from the Family Planning Association—‘The death rate in medical abortions of one in 100,000 was the same as for surgical abortions and lower than the rates for childbirth and ectopic pregnancy at seven and 32 per 100,000 women respectively.’

It is worth noting that in European countries, where RU486 has been available for some time, there has been no increase in the overall number or rate of abortions, but the proportion of abortions performed at earlier gestations has risen. It is true that medical abortions, like surgical abortions, can have serious side effects. Complications, though rare, can include excessive vaginal bleeding requiring transfusion, incomplete abortions or ongoing pregnancy requiring a surgical abortion. There is no doubt in my mind, having read the material, that an appropriate level of backup medical care is needed to ensure that there is speedy treatment in the event of possible complications. Despite the arguments of some that somehow this medication will be readily accessible, the drug, as we know, under the protocols developed by the AMA would only ever be administered by a qualified professional in a licensed facility.

I want to conclude by referring to an article which caught my attention recently. There have been many headlines about RU486 being the killer drug. This article, written by Dr Sally Cockburn, was headed ‘RU486 might be a drug for life’. Naturally, I was most intrigued by the heading and I looked further at the article. It talked about the genesis of RU486. I did not know this—and I think many others who want to argue whether RU486 is or is not a therapeutic drug might have a look at this article—but Dr Cockburn pointed out that the genesis of RU486 began in France in the 1980s, when it was first developed as an exciting new drug formulated to treat Cushing’s disease. She stated:

This drug blocked cortisol and reversed health problems like diabetes. By 1992, research indicated this same drug might hold hope for ageing, cancer, viral and stress related diseases, as well as dementia. The drug offered potential treatment for some of mankind’s most devastating diseases: inoperable brain tumours, ovarian cancer and certain breast cancers.

She went on:

But most amazing were the studies showing it also interfered with replication of HIV …

Dr Cockburn asks: could a cure for cancer or HIV-AIDS be caught up by the fact that RU486 research is, as she says ‘mostly gathering dust’? It is an interesting perspective on the drug RU486, and one which we hear little about.

The intent of the bill before us today is, in my view, reasonably straightforward. I believe that those who oppose the use of RU486—and do so in all sincerity—because of safety concerns have a strong argument to also support this bill. If their concerns about safety are correct, the TGA would not approve the drug for use in Australia.

RU486 has now been used by about two million women. It has been endorsed as safe and effective by people more eminent and with greater expertise than I have—by eminent medical bodies including the WHO, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, similar colleges in both the UK and America, the AMA and the American Medical Association.

By supporting this private member’s bill, we will allow the independent TGA to evaluate RU486 in the same impartial manner that it has done with almost 50,000 therapeutic goods that have already come before it. I believe that the TGA has the integrity and competence to assess whether or not RU486 is safe and suitable for use in Australia.

Sharman Stone (Murray, Liberal Party, Minister for Workforce Participation) Share this | Link to this | Hansard source

I rise to very strongly support the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. Since the Harradine amendment of 1996, no pharmaceutical company has applied for approval for the trialling, supply or distribution of the now restricted RU486. Clearly, after 1996, pharmaceutical companies anticipated that a very costly application for consideration of the safety and efficacy of RU486 would simply not succeed. Consequently, since 1996, Australian doctors have not had the option of recommending a medical rather than a surgical abortion for their patients. So, despite pregnancy terminations being lawful in all states and territories, medical terminations are effectively banned. This surprises the international medical fraternity, who are used to Australia being a world leader or early adopter of best medical practice.

I argue that it is totally unacceptable to have, effectively, a ban on medical abortions in a developed country like ours, where doctors and their patients should expect to have access to the safest medical procedures for a lawful procedure. It is 10 years now since the 1996 Harradine amendments. It is now imperative that we remove the roadblocks that are dissuading pharmaceutical companies from applying to have RU486 evaluated properly.

RU486 has, in those 10 years, become well established as a very safe, non-surgical option for women requiring an abortion. As many other speakers have said, in over 30 countries including France, where the drug was developed, New Zealand, the UK, the USA, Israel, China, Sweden—in all of those countries—the women can expect, when they go to their doctor, to have an alternative to surgical abortions if that is what best suits their condition.

Medical research carried out in these countries and more than one million episodes of the drug’s use have found that the drug avoids surgical and anaesthetic risks and is as safe as surgical abortions, which are very safe indeed. However, unlike surgical procedures, this drug can be used from the earliest stages of pregnancy, and usually that is the preferred process if an abortion is needed—as early as possible. As well, in no country has the use of RU486 led to an increase in the number of abortions performed.

It is important to note that the drug RU486, or mifepristone, is not an over-the-counter product. This is not like the so-called morning-after pill, which has a different but still very important function. RU486 can only be prescribed and its use supervised by a doctor. Protocols for the drug’s use requiring close medical supervision have been mandated in all countries where it is used. You would not expect any doctor, rural or urban based, who was not intending to closely supervise this drug’s use to prescribe it.

The World Health Organisation has now designated RU486 as an essential drug for developing countries. The Royal College of Obstetricians and Gynaecologists in the United Kingdom recommends non-surgical in preference to surgical abortions for women with pregnancies of 49 days or less. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, our most eminent body of specialists; the National Association of Specialist Obstetricians and Gynaecologists; the Australian College of Rural and Remote Medicine; the Australian Medical Association; and the Public Health Association of Australia are all amongst those who ask that RU486 be allowed to go through for evaluation by the TGA, the eminent and evidence based specialist body that assesses all drugs in Australia. And of course they hope that, after that process, there will be an approval for this drug so that they can prescribe it where it is the best option for their patients. RU486 now has at least a 10-year history in its use internationally, and its history is of a safe and effective, non-surgical option for doctors to prescribe—not that those of us in this House who support the bill are trying to call the safety of this drug; we say that it should go to the TGA for its expert assessment.

The further major development since 1996 is that, while the Australian government supports the concept that comprehensive, affordable and confidential reproductive health services should be reasonably available to all Australians, the 1996 Harradine amendment has effectively banned RU486. This has meant that rural women terminating a pregnancy often have a much more traumatic, costly and delayed abortion because surgical procedures are too often no longer locally available to them. In fact, rural communities’ access to any reproductive health related medical procedures—for example, the implantation or removal of a contraceptive under the skin, the insertion of an IUD, a vasectomy or indeed a pregnancy termination—is today far less likely to be available in a rural medical clinic or country hospital than in a capital city.

It is a different world beyond the tram tracks, and I am not just talking about the smallest country towns, where access to medical procedures is limited or nonexistent. For example, none of the doctors, specialist gynaecologists or obstetricians in the city of Bendigo, which has a population of over 100,000, will carry out a surgical pregnancy termination. I am told that no terminations are carried out in my electorate, which includes two rural cities and 50 towns. Rural doctors who recommend or support a pregnancy termination direct their patients to find an abortion clinic in a capital city. That could be a seven-hour drive away. It is a serious issue for a person who is experiencing the trauma of having to think about an abortion to be told they must find their own way to an abortion clinic in the city. They are warned by the doctors or the nurses in their rural clinic that there will probably be protestors waiting to photograph them as they enter the city clinic and they will be abused by the placard-carrying protestors who are rostered on, typically day and night, outside these abortion clinics in the capital cities.

The patient will need private or public transport to the clinic and an overnight stay. Many country women I know have simply slept in a car; they could not afford the accommodation. A rural teenager with little support or a low-income woman or someone from a minority culture who is urgently in need of anonymity find it very hard to make the complex, costly arrangements of finding their way to a city abortion clinic, which typically delays the timing of their terminations by many weeks, causing additional trauma and distress.

Some rural doctors tell me that they do not carry out surgical abortions because of their own faith. I respect a doctor’s right to decide not to carry out an abortion and would expect they would refer their patients to others. However, the majority of doctors do not carry out surgical abortions in rural areas because they no longer perform any surgical procedures of any description. There is a whole range of reasons for that, including their insurance policies, their own experience and their access to hospitals that support their procedures. These doctors believe that the ability to prescribe a drug such as RU486 for their patients is a very important medical option for them. They talk about being better able to guarantee their patients’ anonymity and about it being a safe, more manageable and affordable outcome for their rural women patients. They know the difficulties and the stresses of having to find your way to a city clinic.

These country doctors would prescribe and supervise the drug’s use, of course. Should an emergency arise, their patients would have the same hospital emergency access as any other patient. Rural doctor organisations and specialists have made these same points over and over again, in particular in their submissions to the Senate inquiry into this matter. Doctors in at least three regional women’s health clinics—in Albury, Mildura and Cairns—have now applied to be individual authorised prescribers of RU486. One of these applications has already been in the system for three months. This gynaecologist applicant was told she would have an outcome in several weeks; it has already been three months. Obviously these rural gynaecologists, obstetricians and GPs are saying, ‘Please, can we remedy this current ban on medical abortions in Australia.’ Their patients deserve better.

Like most Australians, I am concerned that too many women—especially teenagers—find themselves in the traumatic situation of needing to terminate a pregnancy. We urgently need to address all of the factors that lead to an unwanted pregnancy, but that in no way negates the need to assist women who are in need right now and have a right to the best possible medical care. On the basis of the impact on rural women alone, I believe we need to repeal the amendment that has effectively blocked access to RU486 in Australia for the last 10 years. Of course, there were no references to rural population consequences during the 1996 debate. Perhaps they were not foreshadowed. Instead, several other arguments were advanced by those supporting Senator Harradine. The first argument was that the drug RU486 had unique characteristics, being an abortifacient. It was then claimed that, because of its special properties, decisions about access to this drug—or even whether it should be trialled—should be made by the minister of the day and not by the expert and independent TGA, which makes such decisions on all other drugs in Australia. Of course, the TGA consults the Australian Drug Evaluation Committee, another panel of experts.

This argument was and continues to be quite spurious. The fact is that the termination of a woman’s pregnancy by properly qualified medical practitioners is legal in all Australian states and territories, according to each jurisdiction’s psycho-social and medical criteria. It is therefore quite inappropriate for anyone to suggest that we should be re-debating the social policy which delivered lawful abortions to all Australian states and territories 30 or so years ago. This issue is, instead, about who is best equipped to assess the safest and best drug alternatives for a lawful medical situation. Quite obviously I believe the task of drug evaluation is best entrusted to the TGA.

The second argument in the 1996 debate was that the drug was so unsafe, as well as being an abortifacient, that its introduction to Australia required extra scrutiny and transparency. Thus supporters of Senator Harradine contended that the new process for evaluation of RU486 would become more effective, transparent and accountable. It became ‘restricted’ and the minister’s unilateral discretion replaced the expert, evidence based TGA process.

The Harradine amendments did not provide any extra levels of efficacy, scrutiny or transparency; in fact, the opposite is the case. The Harradine 1996 TGA Act amendment does not require the minister to notify the parliament or to justify why he might deny a request for a trial, evaluation or monitoring by the TGA. No guidance is given as to the criteria the minister should use or may use in coming to his or her decision on the request. There is therefore no added layer of evidence based scrutiny at all as a result of the Harradine amendment. The opposite effect has been realised and the message has gone out to pharmaceutical companies, ‘Do not bother further with this drug in Australia.’

I will comment on the two amendments submitted or foreshadowed by the honourable members for Bowman and Lindsay respectively. These amendments do not add extra levels of scrutiny to the evaluation of any abortifacient drugs, although that appears to be the stated intention of these amendments. Instead their amendments would either have the minister of the day continuing to make a unilateral decision or place the drug before the parliament for a disallowable period. If only one member brought on a debate to have the drug considered, we would have a re-debate of this issue just as we are doing today.

In these new debates, which would happen again and again—we have to anticipate at least three new debates because we have three applications already before the TGA—we would see the arguments re-run, as we are seeing today, in both the Senate and the House of Representatives. Again, much of the debate would be focused on an anti-abortion stance. This is irrelevant to the issue addressed in the main bill that we are debating today.

Abortion is lawful in Australia. Its legality was settled 30 years ago. We are not redebating that issue. Therefore, I strongly reject the Kelly and Laming amendments. They are simply perpetuating the status quo, which effectively produces a ban on RU486. I therefore strongly support the bill as already tabled. I wish very much to remove the minister’s unilateral discretion and have any applications for the consideration of the use of RU486 or any other abortifacient put before the scrutiny of the TGA.

Let me finally say why I think it is very objectionable that the TGA should be described as faceless men or petty bureaucrats. The TGA has been established to scientifically evaluate and monitor all legal drug access and use in Australia. It is a World Health Organisation collaborating centre, a designation which can only be achieved after consideration of the scientific and technical standing of the institution at the national and international levels, with particular reference to its recent records of achievement and its ongoing activities. The World Health Organisation has assessed the TGA and said it is of international standing and should therefore be a collaborating centre. The TGA, like Biosecurity Australia, is an internationally respected body capable of expert, independent, evidence based evaluation.

I repeat that there is a great deal of distress and trauma in the Australian society as a result of the current outcomes of the Harradine amendments of 1996. We are a developed country. Our Australian women deserve better than what they are able to access today. I am hoping very much that this bill will be supported by all of those in this House, because quite frankly our Australian women deserve better.

Bob McMullan (Fraser, Australian Labor Party) Share this | Link to this | Hansard source

I wish to make it clear from the outset that I will be supporting the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 introduced by the member for Moore. I congratulate him and all those associated with bringing it forward. Coincidentally, I am the first male from our side of the parliament to speak. This is significant only because the Senate vote showed a dramatic gender divide in support for this legislation. It reflects a history of male domination breaking down in our country. On most issues this makes no difference. There has been a lot of rhetoric about how much change it would make, and in most issues it is absolutely irrelevant. But this is one example where the breakdown of the male domination of Australian politics is leading to a change in outcomes, and I welcome it.

Fundamentally, the legislation before us is about process. I want to focus mainly on that question of process. I do not want to repeat the arguments that others have made. We have all been asked to keep our comments brief to allow as many people as possible to speak, and I will seek to do that. The argument in the broad has been put well by many, including the minister who has just concluded her remarks, whose views I share. But we cannot pretend that this is not a process debate without moral overtones, otherwise we would not be having a conscience vote about it. I make my position clear on that: I have always been pro-choice and I remain of that view.

But the process question has been somewhat confused, deliberately. There has been an attempt to render it into an argument about whether in some way the parliament should be supreme, whether elected people ought to be more accountable. It is true that this is the forum in which moral decisions about how the country should be run should be made, not by people with only technical expertise. But what we need to do to implement a majority view in both Houses of the parliament as to issues of morality and conscience is pass a law, not come up with a backdoor process to ban a method of implementing something which is lawful. We are creating here a de facto ban by process.

There are other drugs which the law bans in Australia. It is illegal to possess them and it is illegal to import them—it is not a question of anybody assessing them. You cannot possess these drugs. They are illegal because the parliament has resolved that should be so. But in this instance what we have is a legal process, which is being undertaken in Australia in significant numbers, and a de facto ban on one safe process for implementing it. I am concerned that this process debate has been subjected to a little bit of a red herring.

I am strongly of the view that good governance and accountability matter, that the Therapeutic Goods Administration have the skills and the appropriate level of responsibility to undertake the primary task of review, and that, provided they are allowed to appear before the estimates committee, they are decision makers accountable to this parliament. If the government, the parliament or the anti-abortion lobby want to ban abortion in this country, they should pass a law to do so, to ban the outcome—not put in place a de facto process to ban one method.

As I say, I am unequivocally and long-term pro-choice. The nation supports trusting the women of Australia and recognises that, if we change the process of approval of RU486, there will not be a headlong rush for more abortions; in fact, the international evidence does not suggest there will be any increase at all, with the access to RU486. It will be simply a change to a more convenient and, in many instances, safer and more appropriate method.

It is not that anybody welcomes abortions. They are a necessity for many women that the Australian people have resolved should be lawful. We are debating whether one method should be available to women in undertaking this lawful but not lightly taken path. Women should have access to all the reasonable options available to them so that they can make a safe, informed choice about their future. We should not be making it difficult, embarrassing or risky for them by some technicality, simply because those who are opposed to what they are doing cannot get the numbers to make it illegal.

There are a large number of other arguments that, if time permits, I will come back to. But I want to divert briefly to talk about a parliamentary point in the handling of this issue which I regard as very important. The worst thing that could happen would be for a misunderstanding of process to lead to an outcome not intended by those, when they vote, in this parliament. I refer to the amendment that the member for Lindsay moved in the second reading debate. It is an amendment that is within the standing orders and I do not say that there is anything wrong with moving it, but those who are contemplating supporting the amendment should do so clearly in the knowledge that carrying it will constitute the effective defeat of the second reading of the bill. The wording of the amendment makes that clear and, in my view, that is clearly the intention of the amendment. But whether that is the intention of the amendment or not—and I believe it is—it will be its effect.

If people wish to achieve the outcome of subsequent parliamentary review of TGA decisions—and I do not—the only way of doing so with this bill is to pass the second reading and then support amendments at the consideration in detail stage. If you think voting for the member for Lindsay’s amendment will achieve that outcome, you will be mistaken. That amendment will, if passed as a second reading amendment, effectively defeat the bill. There is some ambiguity in that matter and, if people are in any doubt, I would advise them, as I did when the amendment was moved, to consult House of Representatives Practice. But I am in no doubt and, in my view, the Minister for Health and Ageing and the member for Lindsay are in no doubt that the effect of the passing of the amendment would be to defeat the second reading of the bill.

I urge every member, when considering how they vote, to consider that fact. Some will still vote for it because that is the outcome they want to achieve. While I do not agree with them, that is a proper thing for them to do, if that is their view. But I would hate to see a result achieved by inadvertence or because a second reading amendment is a bit tricky and, by accident or design, people achieve a purpose by a technical amendment with regard to the standing orders.

I will not support that amendment; nor will I support the amendment proposed by the member for Bowman. I thought the member for Bowman spoke well in this debate, but I do not share the conclusion that he came to about process because I do not want to see the second-guessing of the TGA brought here to the parliament once, twice, three times—as outlined by the minister who just spoke—or at all. The core principle of that matter, as it relates to abortion, is resolved in our law at the moment and I do not wish to change it. But, if people wish to change it, they should bring in a bill to do so. To my chagrin, they could do it with regard to my constituency because this parliament could pass a law to make abortion illegal in the ACT. I would be vehemently opposed to that bill, but it is within the power of the parliament to do it. However, nobody has proposed doing it and, in my view, nor should they.

But I do not wish to see a backdoor method of banning a process that has been endorsed as safe and effective by the World Health Organisation, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Public Health Association, the Royal College of Obstetricians and Gynaecologists, the American College of Obstetricians and Gynaecologists, the AMA, the American Medical Association, the International Federation of Gynecology and Obstetrics and the American Association for the Advancement of Science. All those bodies have said that this is a safe and effective process for achieving a legal objective. Therefore, we should not be putting in place a procedural, technical process that would deny effective choice to Australian women in consultation with their doctors. This option should not be closed off by a special one-off process in order to achieve by administrative means what could not be achieved by legislation.

I think the amendments make the situation worse and not better. I see them rather as ‘Groundhog Day’ amendments, where we go again and again over the same debate that we have just had. I urge people, in considering whether to support the amendment moved by the member for Lindsay in the second reading debate, to realise that, should they do so, they will effectively defeat a second reading of this legislation. If that is what they wish to do, they should simply vote against the second reading, as I know many of my colleagues will—although I hope not a majority—and not do so by subterfuge through the member for Lindsay’s amendment.

De-Anne Kelly (Dawson, National Party, Parliamentary Secretary Trade) Share this | Link to this | Hansard source

I rise to support the  second reading amendment to the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 moved by the member for Lindsay. This amendment goes to the heart of the question before us, which is effectively about government and ministerial responsibility and accountability versus the Therapeutic Goods Administration, a group of perhaps expert and very well meaning public servants. The Therapeutic Goods Administration is required to look at safety, quality and efficacy. I note that others have said it is a world-class organisation and it may well be, but it is not infallible. We need to recall that it was the TGA that approved Vioxx for Australia, which was withdrawn in 2004 with some estimated 55,000 deaths worldwide. So no organisation no matter how well meaning or expert is ever infallible.

I want to go to the heart and the crux of the differing arguments here. A proponent of the drug, Dr Caroline de Costa, who has put forward RU486 for approval, made the following statement:

The case for medical abortion in Australia should be judged not on political grounds but solely on evidence-based medical criteria.

That is all very well, except that in response there was a great concern that the drug could not be safely used in rural areas given the risks of incomplete termination, prolonged bleeding and infection. In response to these concerns, the Australian Medical Association said that they strongly supported the availability of medical abortion, describing the report raising these concerns about incomplete terminations and so on as ‘narrow and incomplete’ and criticising the report for focusing on the risks to a minority of rural women who do not have adequate medical backup. This gets us to the crux of the argument. It may be all very well to look at safety, quality and efficacy for a great majority of women in Australia—and I think there is an argument for that but I will come to that shortly—but only ministerial overview and an accountable government will look at the situation for every woman, not say that there is a minority of rural women who do not have adequate medical backup and that therefore they constitute a narrow argument that can be overlooked.

Mr Deputy Speaker Somlyay, coming from a rural area  you would appreciate that it is a very real concern that all women should have medical procedures that involve adequate medical backup. But we are not here to discuss the arguments for and against this particular drug; we are here to argue about the process of approval. But the rural argument simply points out that even amongst expert bodies such as the AMA there can be, if I could put it this way, a pushing aside of those who might comprise an uncomfortable minority.

As I have said, this is not a debate about the merits of this drug—it is about the approval process—but I do want to highlight some of the disingenuous arguments being used to support RU486. I want to refer to the manufacturer Pfizer. This is a dual drug process: women take RU486 in order to achieve an abortion and then take Cytotec or misoprostal. The manufacturer of Cytotec, Pfizer, has warned against the use of the drug on pregnant women, not just because of the danger of miscarriage but also because of other effects. In fact, Pfizer’s only clinical tests have been undertaken on its use for stomach ulcers. As I said, we are not here to debate the pros and cons of RU486, but I think it is very significant that, at the same time we are being told that this is a safe drug, in fact the manufacturer is not prepared to guarantee one of the drugs in use.

The other matter that concerns me greatly is that officials from the Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases in the United States are presently convening a workshop on what they see as a new threat to public health. This workshop will address the virulence of infection in otherwise healthy young women following an abortion using RU486. As I said, we are not here to debate the merits of this drug, but very significant are the disingenuous arguments being put forward to say that the issue of RU486 is very simple—it is a medical procedure; it is safe—when there are others who are very well credentialed who do not see it that way.

I would like to get back to the issue of the amendment moved by the member for Lindsay. What she has included in her amendment is expert oversight—not infallible, as we have seen, but certainly expert—ministerial responsibility and government accountability on the part of the minister for health of whatever political colour and in whatever government, and then, finally, parliamentary debate on the merits or otherwise of the drug in question. More than that, though, the member for Lindsay has required that all decisions be published—that everything be open, transparent and accountable to the Australian people.

It is not unusual for ministers to make decisions. In fact, that is why governments exist: to be accountable and to require ministers to make decisions. We do not, for instance—and I said this yesterday—allow a group of public servants, no matter how well meaning and expert, to make the decision to go to war. We do not allow the ANAO, the DSD, ASIO, ASPI, the service chiefs, our coalition allies or anybody else to make the decision, although all of their expert input and advice is used by the government and the Minister for Defence of the day, along with cabinet, to make the decision to go to war—and it is properly debated in this House. Why, then, wouldn’t we make the decision as a parliament to allow the Australian people access to such a debate through their elected representatives?

I thought it was very interesting to note the concerns of the member for Lalor about the member for Lindsay’s amendment. She said that the manufacturer of whatever drug is in question would not run the risk of parliament. Why wouldn’t they? If they had confidence in their product, had run all the appropriate trials and believed the product was safe, why wouldn’t they run the risk of parliament? Is it that drug manufacturers will not submit themselves to the democratic process? Is that what we are saying? If they will not and they were using that as an argument against ministerial oversight and parliamentary debate, it is a subtle form of blackmail. If drug manufacturers have a product they are confident about, they should be happy to have that product not only overseen by an accountable minister but brought before the parliament and debated, otherwise you would have the ridiculous situation where drug manufacturers were accountable only to a small group of public servants—and I do not think the Australian public would permit that for very long. I am astonished that the Labor Party, who have been crying for the last few weeks for ministerial responsibility—

Martin Ferguson (Batman, Australian Labor Party, Shadow Minister for Primary Industries, Resources, Forestry and Tourism) Share this | Link to this | Hansard source

This is a conscience vote; it’s not the Labor Party.

De-Anne Kelly (Dawson, National Party, Parliamentary Secretary Trade) Share this | Link to this | Hansard source

Let me get to personal aspects of this vote in a moment. The member for Lalor did not mind discussing the Minister for Health and Ageing, so personal elements have already come into this debate and I expect that I can talk about what the Labor Party have said in this debate. For the last few weeks the Australian Labor Party have been calling loudly for ministerial responsibility, of which there is a great deal in the question of selling wheat, yet they do not want ministerial responsibility in the issue of a drug that causes the death of a foetus. The reality is that it is all right to have ministerial responsibility for selling wheat, which this government does, but you do not want to have the minister or the parliament having a look at drug manufacturers. Is anyone going to be accountable to parliament? Absolutely—they should be—and that is what is at the core of this amendment put forward by the member for Lindsay.

The member for Lalor then went on in quite a contradictory way. On the one hand, she said that no drug manufacturer would submit themselves to the parliament, but then she said that the parliamentary process would be swamped by applications and debate. You cannot have it both ways: either they are not going to come here because they do not want to be accountable or they are going to swamp the parliament. If that were the process, and manufacturers believed their drugs to be safe, the reality is that manufacturers would bring their drugs to the parliament, and the parliament would deal with that. We would not be swamped as a parliament; people would not come back repetitively.

There is demonstrable Australia-wide community interest both for and against this issue. We accept that this is an issue that arouses passions and concerns, but the Labor Party want to run and hide from this. They want it kept to a group, albeit a group of expert, though not infallible, public servants. They do not want it brought for the scrutiny of the parliament and the Australian people, and that causes me a great deal of concern. I urge other members in this House to set aside the emotional aspect of this debate; it is about an approval process. There are going to be a great number of drugs coming forward, not only drugs that cause abortion but drugs that will change genetics and change personality—drugs that we cannot even imagine at this point in time. It is proper that the Australian people are, and the Australian people would expect to be, a part of that debate and that process.

They would also expect that drug manufacturers would be accountable to a minister, accountable to a government, and that all aspects of this debate would be open and transparent for them in the parliament. I commend the amendment by the member for Lindsay to the House and ask my colleagues in this House to think very carefully about the way in which they vote, because this is not going to be the only drug. There are going to be many more with many other social, economic and ethical aspects for their approval, and the Australian people will not thank those who do not allow them to be part of such a debate.

Martin Ferguson (Batman, Australian Labor Party, Shadow Minister for Primary Industries, Resources, Forestry and Tourism) Share this | Link to this | Hansard source

The debate about the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 has unfortunately been driven by emotion and conflict principally emanating from remarks made by members on the government benches on the other side of the House. Contrary to a suggestion from the member for Dawson, the previous speaker, I want to make it very clear that there is no predetermined position by the Labor Party, the opposition, with respect to this issue. It is a conscience vote. I want to compliment this side of the House for the mature and responsible manner in which each and every one of us has handled this debate. There has been no public point-scoring against one another, as has been the situation on the other side of the House on the government benches.

Having said that, I want to state very categorically that, as far as I am concerned, this is not a debate about an Australian woman’s right to an abortion—we had that debate a long time ago—and it is not a debate that the broader Australian community wants to revisit in this country. It has come and gone. We should be clear about that fact from the start. This issue is without a doubt a matter of pharmaceutical technical expertise, which is clearly not something the Minister for Health and Ageing, Tony Abbott, I or many others in this House possess. Yet the minister has argued that people should judge his decision on its merits and not on their prejudices—a reference to his belief that people think he has made this decision as a Catholic and not as a minister. I do not seek to argue this, but it must be said that the inflammatory language he has used in this debate as the minister for health does not add weight to his argument that he has made the decision impartially. Warning that use of the drug would lead to ‘backyard miscarriages’ and an internet black market does not help in resolving such a sensitive and emotive issue as the one before the House this evening.

The debate this evening is about making a decision that affects people’s lives. It requires the expertise of a regulatory authority and not an individual, no matter how well-intentioned that individual might be. The Therapeutic Goods Administration is specifically charged with identifying, assessing and evaluating the risks posed by therapeutic goods. It must also monitor and review any risks over time. Thus it is the TGA that is the appropriate authority to assess and recommend on RU486. Prior to 1996, the TGA had responsibility for reviewing and approving all drugs entering Australia but, under the 1996 Harradine amendments, provisions under the Therapeutic Goods Amendment Bill provided that any drug to do with abortion became a restricted good. This debate has, beyond doubt, illustrated the need for an impartial and qualified decision-maker in the TGA process. The decision should be made by the same experts we trust to make the decisions about all other drugs. So far as I am concerned, it is as simple as that.

The reality is that medicines used for any purpose other than abortion do not require the approval of the minister. It is only RU486 and medicines with the same effect which require the minister’s approval. So this debate is not about abortion and neither is it about the safety of this particular drug. What this boils down to is a dispute about who manages the risks associated with allowing the importation of this drug.

We all know that drugs are not perfect. Most have side effects, some worse than others. The point is that no drug is risk free. But there are highly respected bodies in the world that have clearly stated their support for RU486 and they need to be properly considered by experts in Australia. These bodies include: the World Health Organisation, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Public Health Association of Australia, the Royal College of Obstetricians and Gynaecologists of the United Kingdom, the Australian Medical Association, the American Medical Association, the American Association for the Advancement of Science, the Food and Drug Administration of the United States and the Rural Doctors Association of Australia—something that the previous speaker, the member for Dawson, should give some consideration to.

The question is, therefore, whether or not the minister for health, Tony Abbott, really believes that he knows better than all those organisations. Politicians, while having an important role in public scrutiny in many areas, are not drug experts and they should not purport to be so. Only the TGA with its expertise can make that call.

This issue has unnecessarily divided people, causing public confusion, fear and misunderstanding about the safety of this drug. The latest example of the way this issue is being handled by this government is the comments recently by the member for Hughes, Danna Vale. The stupidity of these comments is such that they do not bear repeating, except to say that so far as I am concerned they are an insult to all intelligent people but particularly to the Muslim community. Those comments are not based on fact; they are alarmist and simply wrong. The Prime Minister has shown time and again that stupidity is, unfortunately, not a punishable offence in the Howard government.

This is where the independence and expertise of the TGA is necessary. It is an absolutely essential requirement for the process being debated before the House this evening. Let this drug be properly assessed and evaluated—as it has been, appropriately so, in other countries. It has been approved in Britain, the United States, much of Western Europe, Russia, China, Israel, New Zealand, Turkey and Tunisia. It has been in use for many years overseas. The Public Health Association of Australia, for example, estimates that it has been used by more than 21 million women in more than 30 countries.

I would also like to remind the House this evening of the people this decision potentially affects, and that is more than half this country’s population. This was reflected by the fact that of the 30 women in our Senate, 27 voted in favour of the private member’s bill to overturn the minister for health’s veto over the importation of RU486. Female representatives viewed this matter with an overwhelming consensus: let the decision be made by the appropriate body—the TGA—not a politician.

But this drug is not only of importance to women; it affects men as well. The minister for health and opponents of this drug are not just preventing women in Australia from accessing it. It should also not be forgotten that this drug is being used overseas to treat cancer patients. It is being used to treat breast, ovarian, prostate and other cancers and illnesses. I believe that it is a sad time in Australia when Australians have to travel abroad for a drug available in 30 countries around the world. What this debate comes down to is a pretty obvious consensus, and that is: take it out of the hands of the minister for health and give it to the experts, people appointed on merit by government to the TGA.

This issue goes to the heart of good governance, proper public policy and proper health policy. For the sake of all Australians the TGA should be allowed to make the decision on this drug, as it does on all other drugs not related to abortions. It is time for the minister for health to respect the views of world health bodies, doctors, women and his own political colleagues.

I simply say in conclusion that there is no justifiable case for the minister for health, irrespective of who the minister for health is, deciding whether applications for evaluation of RU486 can proceed. Such a situation is at odds with the evidence based framework generally used to assess other medicines in Australia, and that is the crux of the debate. For this reason I support the private member’s bill and indicate my opposition to the amendment proposed by the member for Bowman and the amendment moved by the member for Lindsay. I commend the bill before the House. In doing so I say to the minister for health: front up to your responsibilities and stop trying to play politics with Australians’ health. It is far too important for simple political games.

Ian Causley (Page, Deputy-Speaker) Share this | Link to this | Hansard source

I am rather bemused that we are even debating the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 in the parliament at present, to be honest with you, because, quite frankly, the drug company Pfizer has not even moved to have RU486 registered as a drug in Australia. So we are pre-empting most of the things that are being said in this parliament. I have to take exception with some of the statements by the member for Batman where he attacked government members for referring to statements from the opposition then proceeded to attack some members of the government. It was rather hypocritical, I would have thought, given the comments that were made.

I cannot come to terms with the argument that says Pfizer will not apply to the TGA to have this drug registered because they have some concerns about the ability of the Minister for Health and Ageing to approve or not approve the drug. The member for Batman went on to talk about some of the other medical benefits of this particular drug. If it has those medical benefits, why has the company not applied to register the product? I would have thought that was the first step. To presume that a minister would disapprove of the drug I think is rather a big presumption.

The other thing I want to say, which I think this has probably been in the debate from a very early stage—it might have been started by the member for Lalor; if not, I will apologise for that—is that the attack seems to be on the minister himself. The debate certainly started that way, with the fact that he was a practising Catholic and he had a view from that particular position. That is a secular argument. I think it is very unfortunate that we are going to get into a secular argument over this particular position. I really do not think that this can be debated any other way than taking into consideration all of the detail.

I have also seen editorials saying that this is not a debate about abortion; this is a debate about RU486. I do not know how you can have a debate about RU486 without mentioning something about abortion, because that is what it is being peddled as: an abortion drug. So that must come into it.

Unlike the member for Batman I do not believe that law is always set in stone. He said that we have had the debate about abortion. But parliaments have the right to change the law; that is what they are put in place for, and from time to time they do change the law. That does not mean to say that the debate over abortion cannot be revisited—of course it can, if public opinion changes. That is what we are about. We are members of parliament; we reflect public opinion.

The other claim that has been put forward, very strongly I might say, by some of the supporters—and I wonder whether this debate is about feminism or whether it is about RU486, from time to time, because I think some of the debate comes down to the position of strong feminists in our society—is that this is all about women’s health. I have had a very strong view for a long time. I do not come from a religious position. Although I claim to be Christian, and I am an Anglican, I do not come from that strong Christian position, but I have always had a view that abortion should only be allowed in certain circumstances: when the woman’s life is at risk, where there has been rape or where there might be some congenital problems with the foetus. I accept that those are valid arguments for an abortion. But I do not believe in abortion for convenience—I do not believe in that at all. I think those are some of the things that we need to take into consideration. A woman has to be in the pink of health to fall pregnant—if she is not in good health, she doesn’t. So I think this argument about health that has been put forward in this debate is a very spurious argument.

The other point that has been put forward, very strongly in some circumstances, is that this is absolutely a woman’s choice. I want to refute that. The last time I checked there was only one major claim about immaculate conception. There are two involved in this. I accept that some people walk away from their responsibilities, but most do not walk away from their responsibilities. During the debate that this House had over the Family Law Act members will have found that a lot of men have some very passionate positions on their children. From my age group, I suppose, I found that rather surprising; but they have very strong views about the fact that it is their child. I think we need to take a close look at that: there are two in this, not just one. I think there needs to be some consideration given to that.

Someone said to me the other day that in the past there were a lot of mistakes. Right through history there have been mistake pregnancies; there is no doubt or argument about that. But let me say: I know of quite a number of these mistake pregnancies, and they are very loved members of families. So just to say, ‘I didn’t plan this,’ and that for some reason, for convenience, you can just abort that pregnancy—I do not take that argument either.

It has been put forward by the member for Batman and others that we should rely on the Therapeutic Goods Administration. This is a faceless group of bureaucrats. They have no responsibility to the people. I thought human life was a little bit more than the clinical, cold consideration of a faceless group of bureaucrats. We have human emotions, and there is no doubt that human emotions come into this. We had a great debate in this parliament about euthanasia, a very good debate about euthanasia. Surely this is in exactly the same category. It is a very strong human debate about whether we should agree with this.

I do not think anyone has seriously taken into consideration the psychological effects this can have on someone. I know at the time women believe: ‘I’ve just got to do something about this. I really don’t want to go through with this. I’ve got to do something about this.’ I accept that that can be a position. But I have also met women who after the event have mourned that lost child for the rest of their lives. Probably not all have done so, but I know that it can have very deep psychological effects on some women. I do not think we take those effects into consideration. I do not know whether we think seriously enough before the termination; there can be some counselling as to what the effects might be. I think that is another thing we need to take very seriously.

The other thing we need to say is that in many ways—and not all; I would say that the community is divided on this debate—the community accepted abortion, as I put forward to you earlier, under very restricted circumstances where they believed there was a problem. But many in the community are asking me, ‘How can you say that 100,000 abortions a year in Australia’—and I know that number is a debated point; I accept that—‘are had due to health reasons, congenital reasons or rape?’ It is very hard to believe that you can come down with that position.

While I suppose I wrestle very deeply with this situation, maybe given the fact that I have a few grey hairs on my head and have seen a fair bit of life, I have come to the view that I have a great respect for life. I think it is one thing that you really have to take very seriously. I do not accept that this or any previous health minister would take a decision that they believed was wrong. I think that is a presumption which is completely wrong. I believe that the pharmaceutical company, if they believe this drug has something to offer, should go ahead with applying for the registration of the drug. How can you possibly say that a minister has rejected this when he has had no application to consider? I think it is an absolutely farcical position to be put. As I said from the start, I wonder what this debate is all about. Is this a debate about RU486 or is this a feminist agenda that is being pushed through the parliament?

John Murphy (Lowe, Australian Labor Party, Parliamentary Secretary to the Leader of the Opposition) Share this | Link to this | Hansard source

I rise in opposition to this private member’s bill, the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. Much has been said already in the Senate last week and in this House, but still more needs to be put to every member of this House in order to demonstrate that the bill is fundamentally opposed to reason, fundamentally opposed to good governance and fundamentally opposed to scientific and moral fact.

This bill is bad law. The consequences of this bill are equally bad law. Why is this bill bad law? I rely on the following points. One, the existing legislative scheme introduced as a late amendment to the original 1996 bill, the Therapeutic Goods Amendment Bill (No. 2) 1996, received bipartisan support in 1996. Two, both government and opposition members supported these amendments, which included critically section 23AA—Ministerial approval of evaluation, registration or listing of restricted goods. Three, RU486 is not merely a therapeutic drug because of its purpose to produce a chemical abortion, and it falls within a special category of drug called ‘restricted goods’. Four, because of this special recognition, the Therapeutic Goods Administration is not in my view the proper agency to administer this type of drug without political scrutiny. The nature of restricted goods means that the decision is not merely a clinical or medical one. Equally, the decision carries higher policy impacts involving social costs above and beyond the notions of freedom of the individual to choose. Hence, the public interest is paramount, specifically with respect to the release of restricted goods to the general public. I believe that it is not the responsibility of faceless bureaucrats to make decisions while operating under the influence of the pharmaceutical corporations.

Five, the TGA is a body dominated and influenced in reaching its decisions both intellectually and, most importantly, financially by medical scientists and the sponsors of these drugs, the pharmaceutical corporations that manufacture them—in this case, the manufacturer of RU486, Danco Laboratories. Six, the Therapeutic Goods Administration is by definition incompetent to administer decision making on dangerous drugs such as RU486. It is by definition non-therapeutic and positively harmful, particularly to women. Seven, the TGA was not envisaged to directly administer restricted goods without public scrutiny. The removal of the minister’s powers without an alternative for public accountability defies the Australian National Audit Office’s fivefold recommendations for greater public scrutiny of the TGA following the Pan Pharmaceuticals debacle. In that case, the TGA demonstrated its failure as an administrator. TGA stands for Therapeutic Goods Administration. What is a therapeutic good? The Parliamentary Library Bills Digest Number 40 of 2005-06 states:

A ‘therapeutic good’ can be broadly defined as ‘a good which is represented in any way to be, or is likely to be taken to be, for therapeutic use’.

This definition in itself does not preclude drugs such as RU486.

What is the statutory definition of a restricted good? The 1996 amendment to the Therapeutic Goods Act inserted the definition of restricted good in clause 1A, which states:

‘Restricted goods’ are defined to be drugs within Regulation 2 of the Therapeutic Goods Regulations (including progesterone antagonists and vaccines against human chorionic gonadotrophin) intended for use in women as abortifacients.

RU486 falls within the definition of restricted good found in subsection 3(1) of the act. Why did this bill receive broad bipartisan support in 1996? It is instructive to read the speech of former Senator Brian Harradine in the debate on the Senate committee report. In part, during the debate on 8 May 1996, he said:

The purpose of these amendments is perfectly clear: to ensure that these particular drugs, which are significantly different in nature to other drugs which are termed therapeutic goods, should not be left entirely in the hands of science technologists and the sponsors of the particular drugs.

As I said earlier, at that time both government and opposition members and senators supported this proposition and voted accordingly. What has changed since then? Nothing. Absolutely nothing. The reasoning in 1996 is as valid now as it was then.

Yet, incredibly, this bill intends to repeal the definition of restricted goods entirely. Equally, the ministerial power presently found in section 23AA is intended to be repealed, along with sections 6AA, 6AB and subsection 57(9). The effect of these amendments is to wipe political accountability entirely from the administration of restricted goods, which include RU486. Instead, all drugs and other items are now to be within the exclusive domain of the TGA. In other words, the purpose of this bill is to entirely remove the distinction between what was hitherto the well-founded distinction between a therapeutic good and a restricted good, and administer the registration of both groups of drugs and other items as one and the same thing. In my view, this bill is flawed on every front: ethically, legally, medically and administratively.

Let us look again, in a little more detail, at the TGA’s performance—or, to be more precise, the lack of performance—as a competent administrator of drugs in Australia. Over the last 10 years alone, the TGA has been the subject of several audits by the Australian National Audit Office. There was the ANAO audit of 1996-97 over the conduct of the TGA’s activities. Fourteen recommendations were made by the ANAO concerning the fundamental operation of the TGA, including the efficiency, effectiveness and accountability of the TGA, including shortcomings in several key areas, including timeliness of decision making, effectiveness of drug evaluation, consultation with consumer organisations and public reporting of adverse drug reactions, specifically, recommendation 12 at paragraph 3.27, which deals with its public reporting ‘to better meet the information needs of Parliament and consumers in the interests of enhanced accountability’.

The ANAO conducted a further report in 2000-01, as a follow-up audit, to review the extent to which the TGA had implemented the recommendations from the 1996 report. Significantly, recommendation 3 at paragraph 3.17 states:

ANAO recommends that, to permit Parliament, industry and other stakeholders to understand variations in TGA’s evaluation performance:

• TGA publish performance indicators of the efficiency of its drug evaluation performance.

These recommendations were supposed to be implemented by 2001. Indeed, we hear the mantra from agencies such as the TGA as noted in the ANAO’s 2000-01 report—that by 2000 the TGA had implemented, or partly implemented, 12 of the 14 recommendations through alternative means. This type of response is used often by government agencies and is synonymous with a ‘substantially implemented’ response. We hear this mantra often in other agencies as well; it is nothing more than a smokescreen. Over the last two years we have seen how ‘substantially implemented’ the changes within the TGA were—how efficient and expert the TGA was—with the eruption of the Pan Pharmaceuticals debacle. We are indebted to Pan Pharmaceuticals. The case demonstrated that all the pencil pushing by the TGA—all the box ticking—means absolutely nothing.

In 2005 the TGA was subject to a third audit by the ANAO, this time over the TGA’s failure to administer its statutory responsibilities for non-prescription medicines. In the 2005 audit, a further 26 recommendations on the conduct and culture of the TGA were made by the ANAO. The ANAO painted the picture that there is a serious cultural issue within the TGA with its ‘rubber stamping’ mentality and its proximity to the vested and sectional interest industry stakeholders it is supposed to be regulating.

The final insult to our parliament and the people of Australia came when the ANAO, clearly frustrated by the apparent lack of progress in changing the culture latent within the TGA, established an audit subcommittee in early to mid 2005 and engaged consultants, Deloitte Touche Tohmatsu, to assist in the ANAO’s work of overseeing and reporting to the secretary on the implementation of regulations designed to address these further recommendations. The consultant, Deloitte, was specifically required to ‘review broader aspects of the TGA’s administration, management and governance structure and make recommendations where appropriate’. In June 2005, Deloitte delivered its findings, stating that ‘the TGA requires holistic, behavioural change, including changes to the agency’s structure and transparency, better governance and accountability, and improved IT systems’. Incredibly, this report was only made available in December last year, some two months ago. In light of this report from Deloitte and the massive underperformance of the TGA, who are we to be giving more power to the TGA, at least until the manifest structural, transparency, governance and accountability issues are resolved?

Compounding this fundamental accountability and structural problem is the issue of bias and influence pervading the culture of the TGA. Who funds the TGA? The Commonwealth Department of Health and Ageing’s annual report of 2004-05 states at page 331: ‘In 2004-05, the TGA received $76.083 Million in funding (revenue) from all sources. Of this, $67.338 Million was from industry fees and charges, $6.177 Million was from the Australian Government, and $2.568 Million was from the sale of goods and services.’ In other words, over 88.5 per cent of the TGA’s revenue is derived from pharmaceutical and other industry fees. Where do they think the greatest influence over the TGA lies? Plainly the greatest influence over the TGA lies in the hands of the pharmaceutical industry. Until the endemic cultural problems within the TGA are sorted out, we as a parliament cannot be so irresponsible as to give the TGA sole responsibility for determination powers over the release of restricted goods such as RU486.

I next touch upon the medical issues of RU486. RU486 is an abortion drug. The intended use is to actually kill the unborn child. This drug is more lethal, more dangerous and more harmful to women taking it than surgical abortion. I ask you to look at the facts—the scientific facts—about RU486. (1) The American Food and Drug Administration website states that RU486 is actually a two-drug prescription. The first drug is mifepristone, of which 200 milligrams are taken orally. Next comes 400 micrograms of the drug misoprostol. (2) RU486 causes the death of the baby by blocking the pregnancy-maintaining actions of progesterone, a hormone of the woman’s body. This is why RU486 is presently classified as a restricted good. (3)The function of misoprostol is to cause strong uterine contractions, thereby emptying the uterus of the dead baby.

This event of forced contractions must be a most traumatic experience for a woman. I understand that this view is shared by key pro-abortion feminists, such as Professor Renata Klein, an associate professor in women’s studies at Deakin University, in RU-486; Misconceptions, Myths and Morals by Klein, Raymond and Dumble published by Spinifex Press, Melbourne.

Edouard Sakiz, then president of French pharmaceutical company Roussel-Uclaf, the original developers of the drug RU486, also states in his interview in Le Monde in August 1990, reprinted in the United Kingdom in the Guardian Weekly on 19 August 1990, that the RU486 procedure is:

... an appalling psychological ordeal because the woman ... has  to ‘live’ with her abortion for at least a week using this technique.

That is, she has to have a dead body inside her body before the corpse is extracted.

I now move to the critical issue of harm to women. First, the drug is not foolproof. RU486 has a significant failure rate. Professor Caroline de Costa notes in the article ‘Medical abortion for Australian women: its time’ in the Medical Journal of Australia, 2005, page 183, that misoprostol fails to cause an abortion in two to seven per cent of women. The Canadian Medical Journal in 2005 reported that the RU486 procedure fails in five to eight per cent of cases in women, thus requiring surgical abortion due to ‘incomplete procedure, excessive bleeding or continuing abortion’. Further, the report of Ravn, Rasmussen, Knudsen and Kristiansen in Acta Obstet Gynecol Scand, 2005, at 84(11) cites an eight per cent failure rate.

I now turn to the issue of safety to women, including the risk of death. There are many references to supposedly authoritative texts saying that chemical abortion, including RU486, is as safe as or safer than surgical abortions. In response to these assertions, I bring to the House’s attention the statement of Dr PD Carney, who is on the board of associate editors of the journal Contraception, who states:

... the death rate from medical abortion  [ru486] among Planned Parenthood patients [is] ... roughly 1.5 per 100,000, compared to a U.S. rate of 0.5 for early surgical abortion.

This means that the maternal death rate for chemical abortion is three times higher than the maternal death rate recorded for early surgical abortions.

I wish to remind the Minister for Health and Ageing of my determination to obtain the truth from him and his predecessors on the exact number of medical procedures procured under Medicare for the purpose of procuring an abortion. I asked question on notice No. 1441 on the issue of pregnancy termination statistics on 13 April 2000 to the then Minister for Health and Ageing, the Honourable. Dr Wooldridge. I was stonewalled. On 7 December 2000 I again asked follow-up questions to Dr Wooldridge for further clarification on the question of the number of Medicare funded pregnancy terminations. Again I was stonewalled. Finally, on 16 November 2004, I asked the present Minister for Health and Ageing and member for Warringah, the Hon. Tony Abbott, whether it was still not possible to estimate the number of late-term pregnancy abortions and what legal impediments prevented him from varying the Medicare codes such that it would be possible to determine the number of Medicare funded procedures that procure an abortion. Yes, again I was stonewalled.

It is clear that successive coalition ministers for health and ageing have not got the political will to establish the truth about the number of abortions carried out in Australia compared with other medical procedures that are not abortions but have the same HIC item number. I question tonight the bona fides of the minister for health. On this issue we come from same constituency. Why did the minister raise 100,000 abortions in Australia, conveniently, a few weeks after the last election? Why did the minister support the Bill Clinton position on abortion last week? Why does the minister duck my questions to him about the number of abortions in Australia every year? Why doesn’t the minister confirm that there are a lot less than 100,000 abortions carried out in Australia each year? Why of all people on this issue does the minister not want to establish the truth? Why does the member for Hughes claim that there are 100,000 abortions carried out in Australia every year? Why did the member for Page just say in his contribution that there are 100,000 abortions carried out in Australia every year? Why do they persist with this false claim?

All members that I have spoken to about this issue want to know the truth. The minister knows that he has the power to establish the correct figures on abortion in Australia. All members of this House that I have spoken to, irrespective of their position in relation to how they are going to vote, would like to reduce the number of abortions carried out in Australia.

I conclude, based on the verifiable and reputable data from medical research on failure rates, we can expect that between 5,000 and 8,000 attempted pregnancy terminations from RU486 per year will fail, thus requiring supplementary surgical abortions, with internal bleeding and psychological trauma. We cannot as a parliament entrust this decision to the TGA. We must take responsibility for the drug and maintain the decision made some 10 years ago in this parliament that RU486 is a dangerous drug that must not be permitted into the market.

Judi Moylan (Pearce, Liberal Party) Share this | Link to this | Hansard source

I have been listening to the debate both in the Senate and in this place and I must say that it is of a very high level, and that is to be welcomed. We have seen this before in these areas that give rise to some emotional input. There has been a little bit of name calling, but I am fairly certain that everyone in this place is pro-life regardless of how we vote on this particular amendment to the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005; none of us want to encourage or in anyway promote termination of pregnancy or see those numbers increase.

There are consequences of going through an abortion. There are consequences emotionally and there are physical risks in any surgical or medical procedure. But the fact is that this should not, in my view, be a debate about abortion. Rather, it should be a debate about providing a process, and for that process to provide an alternative to a procedure that has been legal for many years. My colleague the member for Moore spoke before me, and I would like to restate what he said because I think it is very relevant. He said that currently this parliament sanctions and Medicare rebates surgical procedures with similar risk factors to RU486. I am paraphrasing him slightly; I have not gone through the whole of what he said. I think it is important to restate that point: this parliament currently sanctions and Medicare rebates this kind of surgical procedure that brings about a termination of a pregnancy.

As I said, it should not be a debate about abortion, but rather a debate about a process and about providing an alternative to a procedure that has been legal for many years, a choice that provides women with an alternative to surgical termination of pregnancy. Abortion is legally and safely available under legislation that varies from state to state. These debates went on for many, many years and many of us remember the tragedy of backyard abortions. I doubt that too many people would really seriously want to return to that situation.

This legislation provides the option for women seeking a legal termination to pregnancy to make a choice according to the best medical advice and according to their personal circumstances. Having access to RU486 also provides for a termination at an earlier stage of pregnancy—surely a better outcome than a surgical procedure. Women living in rural communities—and I speak to this because I have many women living in rural areas in my election of Pearce in Western Australia—are disproportionately disadvantaged under the current arrangements. It is sometimes difficult to access facilities and, at a time of personal crisis, these women often need to leave their families and communities and seek services in metropolitan centres, adding to the physical, financial and psychological difficulties.

I believe that in this place our responsibility is to make sure that under the current legislative framework women have access to best practice when they seek a legal termination. That responsibility can best be exercised by allowing the appropriate medical advisory agency, the Therapeutic Goods Administration, to rigorously test the safety, efficacy and effectiveness of abortifacients such as RU486. It has been argued that the TGA, when considering applications for the importation and administration of pharmaceuticals, does not consider ethical issues. However, all pharmaceuticals are subject to high-level scrutiny by independent medical and health ethics committees under the present application approval processes.

Much of the argument to date has revolved around risk, and we heard a lot about that from the previous speaker, the member for Lowe. As risk management is a key function of the TGA, and this agency is made up of independent, qualified and highly responsible individuals, then it must surely be best placed to make a decision. To be safe and comply with state laws, both medical and surgical terminations must have appropriate medical oversight and approval, including, in some states, undergoing physical and mental health tests. It needs to be made absolutely clear that what we are debating in this place today is not a decision about the legality or the ethics of abortion; it is about process, it is about whether or not to allow the therapeutic goods administrator to do its work unfettered by sectional interests and political consideration.

By continuing with the current policy, Australian women are denied options other than surgical termination. As I said before, this also disproportionately impacts on women and their families in rural areas. Women seek to terminate pregnancy for many different reasons, and that must be a decision for them, their families and their medical advisers to determine. Again, I would like to remind the House of the contribution by the member for Moore when he said that the reasons for abortions are unwanted or nonviable pregnancies. Unwanted pregnancy occurs in multiple situations such as foetal abnormality, serious maternal health problems and severe psychological and social problems to mention a few.

If we want to discourage the termination of pregnancy, and I am sure it is clear that many of us in this place do, including me, I believe we as legislators ought to examine some of the issues that give rise to women feeling compelled to go through a termination and what we can do to help women and couples avoid unwanted pregnancies at the starting point. We need to engage in a more robust debate about the kind of assistance we give to women who go through pregnancy unsupported.

Australians have had the debate about the legal status of abortion long ago, and they have supported legislation in our states and territories to allow the termination of pregnancy under certain conditions. Indeed, to look at the public record, one study which was conducted over 30 years by K Betts and published in a paper called ‘Attitudes to abortion in Australia: 1972 to 2003’ indicates that 80 per cent of Australians support a woman’s right to choose whether she goes through this procedure or not. I think it is very important to bear that in mind. There is plenty of other evidence in terms of public opinion and public polling, but overwhelmingly it all points to the fact that most Australians want women to be able to make these decisions along with their medical practitioners and perhaps their families. To continue to ban a medical procedure that has for years provided a safe additional option to surgical termination for women in countries such as France, Great Britain, Sweden and the United States, to name a few, is to neglect our responsibility to ensure that Australian women have this choice.

I believe that my colleagues the member for Lindsay and the member for Bowman are very well intentioned in bringing forward amendments to the bill and trying to find a way through, but I personally cannot support either of the amendments as I do not believe they progress this debate or help with that process of decision making. I have confidence that testing the safety, efficacy and appropriateness of this and other drugs can be safely left to the members of the Therapeutic Goods Administration, and I intend to support the bill.

Nicola Roxon (Gellibrand, Australian Labor Party, Shadow Attorney-General) Share this | Link to this | Hansard source

I want to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 today because I believe that it fundamentally affects the community, particularly women in our community. It is also one of those issues where I think we have to question the appropriate role of government and how much we do or do not want government and individual politicians to interfere with our lives. I strongly believe that, just as we do not want politicians in our bedrooms, we certainly do not want them in our doctors’ consulting rooms with us either.

The idea that the Minister for Health and Ageing, on each and every occasion that the drug RU486 is sought to be used, would make an individual, informed and appropriate decision based on proper technical expertise and the particular circumstances of each case is illogical, unrealistic and inappropriate. I am also deeply sceptical of the argument that ministerial responsibility for approving this drug adds an extra layer of scrutiny or accountability.

If only we could mandate such ministerial approval for the export of wheat, for ‘children overboard’ or for many of the other issues where the government has consistently refused to be accountable. I just cannot buy this as a legitimate argument being made by the Howard government. Even De-Anne Kelly, the former Minister for Veterans’ Affairs, who skated through the regional rorts scandal by saying that it was all the department’s fault, was out there yesterday arguing for the fundamental need for ministerial responsibility. Please! Are we really going to take these sorts of arguments seriously?

Currently the minister is only accountable to the parliament if the decision is to make the drug available. He does not have to notify the parliament if he rejects an application for importation. This is exactly the kind of partial accountability that the Howard government so likes.

But the bottom line for me is this: government has no business interfering in the legal choices that people make about their health care. Our role is to ensure that we have a system in place to ensure that the drugs that are available are medically safe. That is why the TGA was set up. There are very few people in this House who are medically qualified to make that assessment, nor should we be called upon or expected to be experts in this field. Supporting the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 will end the anomaly that has the health minister deciding on the safety and medical suitability of this particular drug.

It is not as if we are talking about some sort of ‘way out there’ drug. RU486 has been licensed for use in France since 1988, in the UK since 1991 and in the US since the year 2000. In European countries where RU486 has been available for some time, there has been no reported increase in the number of abortions performed overall, but there has been an increase in the number of early abortions. As we all know, the safety of an abortion is directly related to how early in the pregnancy it is performed, so this drug may in fact offer a better health option for some women.

So, despite claims to the contrary, this drug may prove a safer option for many women faced with a very difficult decision. But that safety assessment is for the TGA—not for me, as a non-expert politician, nor, I believe, for other politicians—to make. We are not leaving this decision in the hands of faceless bureaucrats, as some have suggested; we are putting the decision in the hands of our medical experts—an institution that was specifically designed to do this work. It will be in the hands of the TGA to decide whether this drug should be available and then in the hands of women and health practitioners as to whether it is suitable for them and whether they wish to use it.

Many of the speeches in the Senate debate focused on the morality of abortion, when really I think the onus is on those who oppose the bill to put the case as to why this drug should be treated differently to any other, given that it is a medical alternative to a currently available surgical procedure. In fact, we are not being asked to decide whether abortion should be legal or in what circumstances it should be available. It is wrong to talk about this debate in terms of whether it is supporting abortion or not. Whether we pass this bill or not, every abortion that currently occurs will be just as likely to occur in the future. We are being asked to vote on who should decide what medical methods of such a procedure will be available to any woman who is faced with this awful decision. And, frankly, I am not comfortable or confident that a minister—particularly the current minister, but any minister—should make this decision.

Senator Brandis, in the other place, has said that this is not a women’s issue. I challenge that. Of course, I accept that a decision to abort will often very acutely affect men as well as women, but it is primarily and undeniably a health issue for women. And, most significantly, the current debate is about restricting access to a drug whose consumers are almost exclusively women.

This bill is about who decides which treatment options a woman has available to her. For me, that falls squarely in the court of being a women’s issue. Many if not most women will consult their partners, their family or friends and their doctors but the decision ultimately should be theirs and all appropriate options should be open to them. For rural women, and for women from some ethnic groups for whom privacy is particularly important, the option of a medical abortion is critical if they are to be treated equally with other Australians.

In this debate I have heard a range of arguments about the safety of this drug, the deaths it has caused, its safety relative to surgical procedures and other medical complications. What this bill is asking is that these health and safety concerns be considered on their merits, without the rhetoric, hysteria, personal beliefs or political sensitivities of any parliamentarian. If, after thorough assessment by the TGA, RU486 becomes available, I have confidence in Australian women to make the right choice for themselves without the interference of politicians in an intensely personal and difficult decision.

Like many other members of this House, I have received a large amount of correspondence on this issue, and I do respect the firmly held and passionate beliefs of those who have contacted me. I particularly value that they have engaged so much in this process and in the decision we have been making over the last couple of weeks. The majority of correspondence I have received from my electorate has urged me to support this bill, although I appreciate that many others I represent will not agree with this position. However, the bottom line in these decisions is not about my view, or the views of many in my electorate; it is about individual choice. We must remember that the legality of abortion has already been determined and that each woman has their own body, their own conscience and their own circumstances to take account of. Just as we are having a conscience vote in this parliament, we should not seek to impose our moral judgments on others. We are the keepers of our own consciences—not everybody else’s. I do not believe that parliament should be some busy-body neighbour or social policeman in our community.

As I said at the beginning, I am strongly of the view that we do not want politicians in our bedrooms or in our doctors’ consulting rooms. Provided that proper medical screening is undertaken when new drugs become available, which the TGA is perfectly placed to do, it should then be left to the women who are contemplating this procedure, with proper support and advice, to decide what is best for them. It is for this reason that I support the bill.

Sussan Ley (Farrer, Liberal Party, Parliamentary Secretary to the Minister for Agriculture, Fisheries and Forestry) Share this | Link to this | Hansard source

I thank the House for the opportunity to speak on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005, which seeks to transfer the approval process for importation of RU486 from the health minister to the Therapeutic Goods Administration. As has been stated, RU486, being an abortifacient, is no ordinary drug and there is no mistaking that this issue is a complex one—indeed, in many cases a personal one—which is invariably the case with issues that require a conscience vote

The correspondence I have received from the electors of Farrer reflects different value systems, different philosophies and different attitudes. There is no single position that I can take on this bill that is in harmony with everyone’s conscience. I pay the greatest respect to alternative opinions, even though I may not agree with them. My own conscience allows me only one option, which is to support this bill.

Like all members of this place I have been weighing up the evidence regarding the use of RU486. I have received numerous emails and letters, both supporting and rejecting the use of this drug, and I have spent countless hours researching the arguments. As I have done so, I have concluded that this debate is about the medical options available to women within the existing framework of women’s access to terminations. This is a debate about the health of women, not a debate about abortion. I do, however, accept that it is quite reasonable for people to use this debate to air their grievances concerning the current state of abortion.

It is important to have this discussion and debate. I have great disquiet, along with all members of this House, about the numbers of abortions in this country, variously estimated at between 84,000 and 100,000 terminations a year. No-one should feel comfortable with this statistic. It is a national disgrace and something that both state governments, which set their own laws on abortion, and the Australian government, which can influence education programs in schools and can encourage good quality counselling, must turn their attention to.

RU486, when used with a second drug, prostaglandin, brings about abortion. So, for many of the people I represent, this debate is about abortion. If I do not confront this I am dodging the issue. With this in mind I therefore propose to make some remarks about abortion. From time to time, particularly as a candidate for election, I have been asked about my position on abortion. My opinions have not changed and I have never sought to hide or misrepresent them. Abortion should be safe, legal and rare. Education and counselling should be the key planks in our efforts to reduce the number of terminated pregnancies. The decision to procure an abortion should be made by a woman, in consultation with her conscience and her doctor.

Many in this debate have brought personal experiences to this place. I have no personal experience of abortion but I often used to think about what I would do if I had an unplanned pregnancy. To the best of my knowledge of myself, I would not choose a termination but I would never impose my view on another woman, either in person or through the legislature of this country. Even if we believe we are protecting a mother’s health or the potential life of the unborn, we as governments should not be allowed to intimidate women into continuing pregnancies.

Abortion raises moral and spiritual questions over which we can and probably should disagree earnestly and profoundly. There is no high moral ground in this debate. A woman who makes a decision to proceed with a pregnancy is not a better person because of her decision than one who seeks a termination. I urge those from both sides of this debate who would criticise and condemn to walk a mile in the shoes of the people whose views offend you. Amidst the sound and fury directed at me as a member of this parliament, I am reminded of a saying from the French novelist de Balzac: the more you judge, the less you love. How true that is. I have taken time to address the abortion question because my constituents who are opposed to the bill have couched their opposition in terms of abortion itself being a moral wrong.

May I now return to the substance of the bill: the approval process for RU486 leading to it becoming available in Australia, as opposed to maintaining the status quo. I have been asking myself, ‘Is this drug safe to use for women who live in rural and regional Australia—women such as those in my electorate of Farrer who may not have immediate access to either a doctor or to surgical abortion?’ Once the decision has been made to terminate a pregnancy, the safety and effectiveness of medical as opposed to surgical abortion is a question that needs answering.

So how safe is RU486? Reports vary widely, but there have been at least 10 reported cases of women dying because of complications linked to the drug. There have also been women who have needed immediate medical attention due to adverse side effects. This has to be weighed against the number of successful uses of RU486, which has been used by up to one million women worldwide over the past 18 years. I think the answer lies not in the use of the drug itself but in the way our health system and health professionals administer it and care for the patient both before and after its use. What is important for patients is to have the option of different methods of treatment, because not all patients will be responsive to, or indeed want, certain kinds of treatment.

Australia have one of the best systems of checks and balances when it comes to the approval of medication. Not only do we have the TGA to assess the safety of medications; we also have highly skilled, well-trained doctors, nurses and allied health professionals. For the most part, we have world-class hospitals and medical centres and a variety of professional organisations and standards of practice which monitor the qualifications, behaviour and conduct of our professionals. I do trust the experts to evaluate the data from overseas—including the claims of serious adverse health effects from RU486—and to come to an informed view about the risks versus the benefits. Furthermore, I trust our local medical professionals, some of whom I know are ethically opposed to this drug and will therefore not prescribe it. Doctors will decide whether they prescribe RU486 for some, all or none of their patients.

It has been argued that RU486 will make obtaining an abortion easier. I have seen no evidence that pregnancies would be terminated with RU486 which would otherwise continue. If anything, I believe the drug will mean terminations will happen earlier rather than later in the pregnancy. This is particularly applicable to rural and remote women. So I do not believe RU486 will cause more abortions. The drug was first introduced in France in 1988 without any noticeable increase in the abortion rate. Similarly, in England there was no increase in the number of abortions, and in Sweden there was a slight decrease following the approval of medical abortions.

I hope there is not an implication that a woman choosing termination should not find it too easy. I hope no-one feels that such a woman should face maximum difficulty in procuring the termination, that it should be a process that is as difficult as possible for her, or that we should accept a regime where, say, a young woman on a low income with no family support has to travel for hours—say, from northern rural Australia to Mildura or from rural Victoria to Melbourne—possibly in secrecy, to run the gauntlet of placard-wielding individuals who scream at her in protest and then, after a fairly traumatic procedure, make the trip home again alone to deal with the aftermath. We should not wish to punish women who choose to have a termination. Are they not punished enough by their families, possibly their partner and those who would seek to pressure them into a different view, but most of all by their own conscience? I refuse to accept that anything but the smallest minority of women seeking a termination are not hugely traumatised by the process. I wish the House well with its deliberations. I support the bill as presented.

Annette Ellis (Canberra, Australian Labor Party) Share this | Link to this | Hansard source

I rise tonight to address my remarks to the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. First, I would like to thank the majority, thankfully, of speakers who have come into this debate before me tonight, particularly the Parliamentary Secretary to the Minister for Agriculture, Fisheries and Forestry, who has just completed her words, and also the member for Jagajaga and the member for Murray. I had the pleasure in both cases of hearing most of their deliveries in this debate.

The bill is really all about the ability for the Therapeutic Goods Administration to make the determination in relation to the provision of a drug in this country rather than to have a political process do that. My one major critical comment would be that I have been really sorry to see the levels of hysteria that have been coming into the debate in part. I understand that this is a very controversial issue for some, and I respect that. But I do not believe that the injection of hysteria helps anybody. I believe it confuses the issue. It does not help those who are still attempting to deal with it within themselves. Over the last few weeks we have seen people raise issues which have had, frankly, nothing to do with the bill before us.

Most members who I have heard speak have said—and I agree—that this is not actually a debate about the right to abortion. That is a debate we had a long time ago, and that is not what we are here to discuss, although I agree with the previous speaker that many people are seeing it through that prism. The debate, in my view, is really about one thing and one thing only: who should in fact decide on the safety of the use of this medicine in that technical sense. That is where the debate basically begins and ends for me. On that basis I believe that the debate is really fairly straightforward. I strongly believe that medical experts should assess the safety of the drugs that come before us in this country, not us as politicians.

I have had the pleasure of being in this House now for almost 10 years. Over that time there has been many an occasion when people, sometimes in their tens and sometimes in their thousands, have written to people in this place, including me, seeking our assistance in lobbying hard for the provision of a medical drug of one sort or another—to get it onto the PBS, to get it accepted into the country in the first place—for particular use. Some of these treatments have been for chronic illnesses like Alzheimer’s disease and arthritis. There has been a long list of them. It is very tempting in cases like that to get bound up in the emotion of it, to want to help influence that process for the approval of those drugs into this country and to see yourself as helping people with those chronic illnesses who are desperate to find a solution to their health issues. However, I have always supported the current system in Australia, where the safety of and the access to those drugs is determined by medical experts through the Therapeutic Goods Administration and not through us in here.

When some people have written to me in the past on questions like this, I have done the right thing as a local member supporting their views and forwarded their submission on to the minister concerned at the time, knowing full well that the minister’s response will always be: ‘This is not a determination I make but a determination for the experts to make.’ Politicians are not those medical experts. We are not given that job to do. We do not currently decide which of those drugs could be available in this country, and I do not see why this one should necessarily be treated any differently. Medical experts currently decide how safe a particular drug is and whether it should be available in this country. That process should be consistent for all drugs—and, to date, that has been the case.

Many myths have been brought into this debate. As I said a little earlier, I have been saddened and a bit frustrated by the level of hysteria that a small number of people—nevertheless, loudly—have been trying to bring into the argument, confusing many people who have very sincere and deeply held views. We have heard the comments made last night and today by the member for Hughes and I will not go over them again. We have also heard the member for Lindsay—I think it was—begin to debate the issue of adoption of children from China while asking a question about the comments of the member for Hughes and about this discussion generally.

We know, as the member for Jagajaga and other members in this House have said, that the Minister for Health and Ageing has said that the use of RU486 will lead to ‘backyard miscarriages if unscrupulous doctors prescribe these drugs for desperate women’. I find that particularly offensive. Doctors have no more reason to be irresponsible with this drug than with any other drug. I think it also reflects adversely on women, in whom we need to place some trust.

Those who want to see the authority for this drug remain with the minister—particularly some of those on the government side—have argued, in respect of the amendments, that government accountability is paramount and the only way to maintain that principle is for the Minister for Health and Ageing to maintain his role with this particular drug. I do not mind if we have factually based arguments or debates in this regard, but I do mind desperately when we start to hear what I would call nothing other than hysterically funny comments. Comments have been made about the faceless people who run the TGA, as if it is some secret society, and that the only way we can have accountability is for the Minister for Health and Ageing to have his hands on this particular process.

Here in my electorate in Canberra, we have been screaming out for government accountability to, in fact, remove some faceless people from procedure. The National Capital Authority comes to mind immediately, where the minister for territories has been absolutely hopeless in making certain decisions on behalf of this town, saying, ‘It’s the NCA who do it; the NCA has the decision’—and that is the end of the line. There is a certain hypocrisy in running an argument when it suits you and in ducking out of it when it does not. The government continually slide away from accountability, pushing everything in front of public servants—and anyone else, for that matter—but some of them still stand up and run this argument in relation to this particular question. I find that just so hypocritical.

I want to finish with two comments. I want to thank very sincerely those people from my electorate who have contacted me by email, phone and letter with their views on this issue. There have been many of them and their views have come from all different sides of the debate. I have to say that the majority have been in support of what I am about to do, but I want to thank all of them. It is part of our democratic process and to all of those people I intend, where at all possible, to send a reply, explaining to them, regardless of their stance, the decision I have taken and why I have taken it.

I reject the two amendments that have been put forward by the member for Bowman and the member for Lindsay. I support and endorse the bill in its entirety. I hope that, at the end of this process, all in this place will continue to hold regard for each other, which will enhance the democratic process in which we find ourselves. I hope that those who decide to inject some unwanted hysteria into the debate cease to do so once the vote is taken, no matter what the outcome is, and that we can get on with doing the best we can for our communities accordingly.

Christopher Pyne (Sturt, Liberal Party, Parliamentary Secretary to the Minister for Health and Ageing) Share this | Link to this | Hansard source

I will be voting against the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. Much has been said in the Senate and the media regarding what this debate is about. To me, this debate is about making abortion more readily available than it is. I will not vote for a bill that could potentially make access to abortion more readily available than it is now.

The effect of the bill is to remove the capacity for the Minister for Health and Ageing to declare a product a restricted good under the Therapeutic Goods Administration Act and to repose all power in the TGA in relation to potential restricted goods. The only product currently declared a restricted good is RU486 in its application as an abortifacient. RU486 induces a miscarriage leading to an abortion in the first three months of pregnancy; therefore, this debate is about abortion.

I understand that there will be abortion in this country and I do not support a return to the dark days of backyard abortions and the like. But I do think late-term abortions are wrong. I do think it is a travesty that, in hospitals around Australia today, babies are being born and living after 21 weeks of gestation and, in other parts of the same hospital, babies of the same gestation and longer are having their lives brought to an end. I do believe that a woman having to see her doctor and go through a surgical procedure performed by a doctor gives her time to pause, reflect and change her mind.

The hope of the proponents of this bill is that it will remove to the TGA a decision that is currently in the hands of the Minister for Health and Ageing. They believe that RU486 should not be treated differently from any other drug. But the proponents of this bill are missing a vital element: RU486 is not like any other drug. It is not a therapeutic product; it is an abortifacient. It ends life. It does not assist people to get better, grow older, improve their quality of life or remove pain, like other therapeutic products. It inhibits therapy, it induces miscarriage and it leads to the death of a potential human being. For that reason alone, this power should remain with the health minister.

The people elect us to make tough decisions. We have to stand or fall by those decisions at the ballot box. The same cannot be said of the good officers of the TGA. The TGA has the remit to assess and regulate therapeutic products. It is an agency of technicians and scientists, not of ethicists. Every member of this House is many things, including an ethicist. RU486 is an abortifacient. Its use necessarily involves an ethical or moral decision. It is not aspirin or penicillin or a new surgical device. It is not like any other drug. To treat it like any other drug is to propagate a fallacy. As politicians it is our job to make these decisions. The public expects leadership from us on ethical matters. Our opinion informs theirs and vice versa. They elect us to lead, not to dissemble.

It is worse than the ostrich with its head in the sand for us to pass off decisions of this nature to the TGA. It is irresponsible. It is worse than a crime of omission; it is a crime of commission. There are amendments being put that would both have the effect in different ways of making a decision of the health minister, in the case of the member for Lindsay, or a decision of the TGA, in the case of the member for Bowman, disallowable instruments in either house of parliament. I will support either of those amendments in turn because they are an improvement on the member for Moore’s bill. They at least contain an element of parliamentary oversight and, in the case of the member for Lindsay’s amendments, a degree of ministerial responsibility. They recognise that there is an ethical aspect to the use of abortifacients and that we have a responsibility as politicians to use our judgment and experience to decide on these matters.

We are all informed by our experiences, our upbringing, our education and our knowledge—and, in many cases, our faith. Sometimes in this debate there has been a tendency to imply that someone who has a particular viewpoint holds it because they are of a particular religious persuasion. It is an ignorant point of view. Those who do not have a particular religious faith—be they atheists, agnostics or simply lapsed Christians—do not have a monopoly on dispassion. They do not hold the holy grail of objectivity. Those people are as informed by their experiences, upbringing, education and knowledge as anyone else.

I do not hold to the view that a Christian cannot approach the issue of abortion objectively any more than I subscribe to the view that an atheist is someone who does not have a value system that places a premium on human life. Both attitudes are insulting and wrong. But I do believe that Christianity has been the single most important force for good in the history of mankind simply because its central tenet is to do to others as you would have done to yourself. That does not mean that churches that represent Christianity are not without fault, but the implication that a health minister cannot be trusted with decisions on abortifacients because they happen to be a practising Christian is shallow and false.

Incidentally, the simply truth is that there has been no application to register RU486 as an abortifacient in Australia throughout the tenure of the first two health ministers of this government. The move to take away this power began before any application was made to use RU486 as an abortifacient in this country. The power to declare an abortifacient a restricted good should remain with the minister. The longstanding Westminster principle of the executive being responsible to the parliament for their decisions will be maintained by voting to maintain the status quo—and I would urge the House to do so.

Anthony Albanese (Grayndler, Australian Labor Party, Deputy Manager of Opposition Business in the House) Share this | Link to this | Hansard source

I want to speak in favour of the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 and against the amendments that have been either moved or foreshadowed. The debate about RU486 has not been properly represented. This debate has been corrupted and hijacked in ways that were predicted by many. Firstly, I will put what this debate is not about. It is not about abortion. That is within the control of the states. It is also not about whether RU486 should be approved. It is about the process of approval and whether it should be subject to ministerial discretion or whether it should be, like other drugs, subject to the approval of the TGA.

Egos and morals have muddied what should have been a clear debate about good governance around the process of assessing the safety of a drug and approving its use in this country. It should have been simply about correcting the politics of what is a clouded past which led to the introduction of this as an exception—about clearing away the political hangover and placing the decision about the health of Australians back in the right hands, namely the TGA. This debate should not have been nor should it continue to be about abortion.

We have had the debate on abortion in this country, and overwhelmingly the public supports a woman’s right to choose. Australian women have fought this fight before and have won. Women have fought for their right to choose and have control over their bodies in consultation with their doctors. In many ways, we are indebted to the struggle undertaken by those women. They fought long and hard to stop women having to resort to dangerous backyard abortions—because abortions will take place; they always have. The issue is whether or not they take place safely in the interests of those women.

At the moment abortion is safely and legally available in Australia. Abortion in Australia is regulated by the states. It is not the role of this parliament to interfere with state policy and law, nor is it the role of this parliament to curtail the regulatory scope of the TGA. Decisions about the health of all Australians need to be made on the basis of medical evidence by experts charged with this role of risk assessment—namely, the Therapeutic Goods Administration.

The word ‘therapeutical’ has been bandied about in this debate, used by some to further cloud what should be simply issues of process. It has been used by some to imply that the nature of the work that the TGA does is marginal. It has been implied that the TGA can only assess restorative drugs. The TGA is charged with the task of assessing the safety of every other drug used in Australia—50,000 drugs which Australians rely on every day.

One of the issues underpinning this debate has been the issue of risk and the notion of an acceptable risk to women’s health. Numerous professionals have argued that RU486 constitutes a relatively low safety risk. The AMA has argued that the drug certainly is safe and notes that over one million women have been treated worldwide. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has noted that there is a substantial body of literature establishing the safety and efficacy of mifepristone, while the World Health Organisation included RU486 on the list of essential medicines, describing abortion—surgical or medical—as one of the safest medical procedures. Indeed, RU486 is extensively used and has been approved by 35 countries, including the UK, France, the US, Spain and New Zealand. The fact remains, however, that these theses, endorsements or otherwise are best evaluated by experts, not politicians.

The TGA’s risk management role means that it is specifically charged with identifying, assessing and evaluating the risks posed by the goods which it regulates. The TGA’s own report states that it will apply any measures necessary for treating the risks posed and monitoring and reviewing the risks over time. The TGA is charged with this role by the government. It is more than qualified to evaluate the risks associated with RU486, unlike me or the Minister for Health and Ageing.

The amendment proposed by the member for Lindsay is more about staving off another split in the coalition’s ranks than about making an informed decision about this drug. There is no need for the parliament to again consider the decisions reached by the TGA in relation to RU486. Yes, politicians are accountable to their constituents and the TGA is not, but politicians do not have the necessary expertise to assess the safety of a drug, unlike the health experts appointed by the government to do exactly that. If a woman is faced with an unwanted pregnancy, she is the best person to assess the moral implications of that pregnancy, just as the TGA is the best group of professionals to assess the safety of her various termination options. I have always advocated, and will continue to advocate, that decisions regarding women’s health issues should not be made by politicians; they should be made by women themselves in consultation with their doctors. I do not believe that any man can understand what an unfortunate, regrettable, difficult situation women can find themselves in.

I have been emailed by a number of people of various views asking that I vote for or against this legislation. This is a conscience vote, and I intend to exercise that in accordance with my own conscience. I respect the fact that some people would not agree with me, but I think it is unfortunate that some of the contributions to this debate—on both sides, it must be said—have not been constructive and have not shown respect. I think it is absurd that the minister for health has attempted to make this an issue about himself. It is not about him; it is about women in Australia and their right to choose what happens to their body at a particular point in time which is difficult for them. I do not believe that the disagreement with the minister for health is about his religion and his Catholicism. I know that people of religious views have different views here, but I do not believe that people’s objections are about the fact that Tony Abbott is a Catholic. I am half Italian and half Irish and belong to a party that has its foundations in and a great closeness over its history to Catholicism. I think it is about the fact—and if you look at the Senate vote, you will see that it has reflected this—that men, in particular, do not have the same understanding, nor can we, as women have on this issue. I am sure that, if there were a women-only vote in this House, there would be a considerably higher majority than there will be, I hope, when the vote is carried here. That dimension has been an unfortunate reality.

The comments by the member for Hughes have also been unfortunate. I find it astounding that, at a press conference supporting an amendment to this bill, she should raise the issue of Australia becoming an Islamic nation over the next 50 years. They were inflammatory comments designed to create fear and division in the community. I think the comments were very unfortunate, inaccurate and best not said.

There have also been contributions on the other side of the debate, including the wearing by Senator Nettle of a T-shirt carrying the slogan ‘Tony Abbott, keep your rosaries off my ovaries’. I believe that is highly offensive to Catholics and that it is entirely inappropriate for someone who is an elected senator in the Australian parliament to wear such a slogan. If it were a similarly offensive statement against Judaism or against Islam, it would be equally outrageous and might have provoked a greater outcry.

I really think that we have a responsibility to have a responsible debate about these issues. I commend the fact that most people on both sides of this House and on both sides of this debate have done just that. I urge the parliament to support the bill and not to be distracted by amendments that are designed to confuse the issue and have a revisiting of the bill. I urge them to reject the amendments and support the bill because, surely, the TGA is the body in Australia that should have scrutiny of the health and medical treatments available to Australian women.

Peter Lindsay (Herbert, Liberal Party) Share this | Link to this | Hansard source

I would like to start my contribution to the debate on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 by observing how interesting it is that in a conscience vote matter the quality of the debate in this place certainly rises above the norm. I found it interesting listening to the member for Grayndler, who is normally a left-wing communist in this place—and that is being kind.

Anthony Albanese (Grayndler, Australian Labor Party, Deputy Manager of Opposition Business in the House) Share this | Link to this | Hansard source

Oh, come on!

Peter Lindsay (Herbert, Liberal Party) Share this | Link to this | Hansard source

I withdraw that remark—though it was said in a kindly way, Member for Grayndler. The contribution of the member for Grayndler was very thoughtful. I am actually paying him a compliment on the way that he even-handedly dealt with these particular issues. I found myself agreeing almost entirely with what he said.

I want to thank the many people who have contacted me with their contributions and assistance, as they have contacted many members of parliament. I have certainly taken note of all the correspondence that I have received, and it has been quite voluminous. However, those who have written or emailed me saying, ‘If you’re not going to vote the way I want you to vote, I’m not going to vote for you at the next election’ do themselves no good at all. When members of parliament come into this place they vote as they think they should vote, not in accordance with whether or not they are going to get another vote from somebody else. I say to those people: ‘You devalue your contributions by threatening that action.’

The contributions, help and information that I have received have come from those on both sides of the debate, and have been very passionate. It has been interesting to hear those contributions. Those who want this bill to be voted down will say things like, ‘This affects the issue of abortion and the very fabric of society’; that government is set up in this country so that parliament and its members are directly accountable to the whole community; that the government sets up consultative regulatory bodies, such as the TGA, to advise and administer on its behalf but that these bodies are not directly accountable to the community or the electorate and are not the government itself—rather they are simply the enabling machinery of government; and that the ultimate result of such undermining in allowing administrative bodies to make decisions is to weaken the institution of government and, in final effect, to begin to make a route to anarchy.

Government has many departments and many advisory bodies, and I think it is clear to the parliament that we do rely on advisory bodies and government departments to make a number of technical decisions on behalf of the government. And they do it well. It would be impossible to have the parliament review every decision of every advisory body in every government department. It just would not be possible. Parliament would be dysfunctional. So I reject that line of reasoning.

Those on the other side of the debate say that there is overwhelming evidence, based on numerous studies and clinical trials, to support the statement that RU486 is safe and efficacious for medical abortion. They go on to give all sorts of reasons why that is so. I found it fascinating to get two pieces of correspondence from two doctors, based on their experience in the Northern Territory. The first doctor was from the Darwin hospital. He said:

I write as a medical practitioner ... working in Darwin. I regularly consult in remote Aboriginal communities as part of the Surgical Outreach Program of the Royal Darwin Hospital.

I am concerned that ... RU486 has been recommended for women in rural and remote locations. In fact it has been claimed that it will fill a gap in abortion services in these areas. There are a number of reasons why such a proposal is not only ill-considered, but dangerous.

The doctor goes on to argue against what this bill proposes. Equally, I have a letter from a medical practitioner who is now living in my home city of Townsville. He has some experience with remote area medicine in north-west Queensland and the Northern Territory. He says:

I write because I believe that the drug ... RU486 ought to be available for the patients that I have looked after. I believe that it is quite anomalous that Australian women do not have the option to use ... this drug whereas therapeutic surgical termination of pregnancy is available in Australia and both the medical option using [RU486] as well as surgery is available for women in comparable countries overseas.

The specific ban on this drug seemed to me to be quite an extraordinary measure motivated by Senator Harradine. It seems that this senator wanted to inflict his minority world view in terms of abortion on the general Australian population, but could not succeed in an outright ban on the procedure, but because of the political situation at the time was able to impose a restriction on this drug which was without medical basis.

My life experience over my 56 years has shown me how devastating it can be to mother, child and society to have unwanted pregnancies which are continued to term because of the unavailability of appropriate therapeutic abortion after due counselling. I therefore strongly urge you to vote for the lifting of the ban on this drug.

So the parliament and all of its parliamentarians are faced with conflicting views from the medical profession. But I appreciate receiving those views.

Perhaps the most compelling view that I received was from the National Assembly of the Uniting Church in Australia. All of us have received a lot of correspondence from the churches and from their parishioners. I think the Uniting Church are very even-handed in this debate. The Uniting Church start off by saying:

The Uniting Church believes that human life is God given from the beginning. We believe that all human beings are made in the image of God and that we are called to respect the sacredness of life.

We also believe Christians are called to respond to life with compassion and generosity.

When abortion is practised indiscriminately it damages respect for human life.

And I think that is true. The Uniting Church continue:

However, we live in a broken world where people face difficult decisions. Respect for the sacredness of life means advocating for the needs of women as well as the unborn child.

This is the key to their view:

We reject two extreme positions: that abortion should never be available; and that abortion should be regarded as simply another medical procedure.

It is not possible to hold one position that can be applied in every case because people’s circumstances will always be unique.

It is important that women have the space they need to make an appropriate decision after careful consideration. The current abortion laws allow women to do this in whatever circumstances they face.

The Uniting Church go on to say:

Women must be free to discuss their situation before they make a decision. The Church needs to be a place where such discussions can happen. We can offer spiritual, moral and pastoral support to a woman at this time.

Whilst we encourage our Ministers to remind people of the sacredness of life, the Church’s role should be to offer care and support leading up to and following a decision, not stand in judgment.

The church then conclude by saying:

The decision to have an abortion is not just a moral issue but a social one. While the current debate attempts to pass moral judgment on the act itself, it ignores the many emotional, physical, financial and social issues that often create a situation where a woman is forced to consider an abortion.

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

I can assure the church that I have not lost sight of those particular issues. My decision on this bill is clear cut. I believe that there should not be a situation where just one drug comes up for the approval of the minister. We should have consistent policy. All drugs needing to be available in Australia should go through the TGA. I leave it to the TGA, the professionals and the health professionals to decide whether they should be prescribed.

I note that RU486 is also used in the treatment of brain tumours and prostate cancer. It would be a shame if those people who had brain tumours and prostate cancer could not have access to a drug that may help them enjoy a better quality of life.

So I leave it to the medical profession and to the women of this country to make decisions as needed. I mightily respect the Uniting Church for their even-handed view on this particular issue in such difficult circumstances. I will be supporting the bill when it goes to a vote.

Ann Corcoran (Isaacs, Australian Labor Party, Shadow Parliamentary Secretary for Immigration) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 is about whether or not the health minister should have the authority to stop the use of a particular group of drugs in this country. Before any drugs can be used in Australia they must be assessed by the Therapeutic Goods Administration. If the TGA is satisfied that the drug meets standards for quality, safety, efficacy and timely availability, it approves the use of the drug within this country. Part of the TGA’s assessment process is an evaluation of the risk associated with the drug—that is, the potential of the drug to do harm to those it is intended to help and to others who may come into contact with it. The assessed risk of the drug then determines whether the drug is registered or listed. Registered drugs must be used under a doctor’s supervision; listed drugs do not require a doctor’s supervision.

At present a certain group of drugs—ones that are intended to induce an abortion—are treated differently from all other drugs in Australia. Drugs in this group, of which RU486 is the one most commonly talked about, may not be evaluated, registered, listed or imported without the specific approval of the health minister of the day. The minister must notify parliament of any decision he or she makes to approve an application for a drug in this category to be evaluated by the TGA. The minister does not have to report any decision he or she makes not to approve an application for evaluation.

It should be noted that under current arrangements there is no technical reason why someone—a doctor or a sponsor—cannot apply for permission for the drug to be used in Australia for circumstances other than abortion. In fact, no-one has applied—until, I understand, very recently. It is thought that the reason for this is that no-one is prepared to go to the significant costs and effort involved in an application to the TGA when the minister can just dismiss the application. The effect of the added step of gaining ministerial approval has effectively been a ban on these drugs since 1996.

The object of this legislation we are debating today is to bring this group of drugs into line with all other drugs in the country in terms of the process for approving or not approving the availability of these drugs within Australia. The discussion within the community about this bill has been broadened beyond the technical object of the bill to include discussion about abortion and whether or not we ought to allow abortion in this country. It is understandable that the debate has broadened because of the nature of these drugs—they are, after all, intended to bring on an abortion, and this is a very controversial issue.

I, and no doubt most other MPs in this place, have been lobbied by a number of people on both sides of the abortion debate. Some people want us to pass this bill; others want us to vote it down. The people who are asking us to vote this bill down do so because of their strong views that abortion is wrong. One argument for voting against this bill is that we—that is, this parliament—should not pass responsibility for decision making about abortion to unelected officials. It is worth noting in passing that abortion is a state issue, but I do not want to get technical about it, because the principle of the thing is what is important.

Let me deal with that side of the discussion right now. It can be dealt with very simply. This bill is just not about whether or not abortion should be allowed. It is important to understand that this bill does not change any current laws about abortion. This bill does not make an abortion easier to get or more difficult to get. This bill does not change the existing laws that govern abortion. It is also important to make the point that passage of this bill does not mean that RU486 will be immediately available or that it will be rammed down the throats of unwilling women, which are some of the things we have heard. What this bill will do, if passed, is simply put the decision about whether or not a group of drugs which are designed to induce an abortion are to be made available to people in Australia.

By passing this bill parliament is not abrogating its responsibility to make decisions about important matters—abortion in this case. The decision about whether or not we as a society approve of abortion is not part of this bill. This bill simply allows the TGA to decide whether or not a drug that brings on an abortion is safe to use. It does not alter how the decision to abort or not to abort is taken.

If this bill is passed by parliament, the question of whether or not people in Australia have access to the drug RU486 and other like drugs will be decided by the TGA. It will be decided by scientists and experts, and the decision will be based on the grounds of safety. Access to the drug will no longer require the approval of the present or indeed any future health minister. If this drug passes the strict tests of the TGA, it will mean that women—with their doctor’s guidance and advice—may be able to choose to have a medical abortion instead of a surgical abortion. I want to stress again that the medical abortion will be available only if the TGA judges that the drug meets Australian standards for quality and safety. The effects of this bill can come into being only when and if a decision to undergo an abortion is taken. Once a decision is taken to undergo an abortion, this bill if passed may broaden the options available to that woman and her doctor.

An argument has been put to me by some people that this bill ought to be rejected on the grounds that the drug is unproven or unsafe. The assessment of the safety of this drug is actually the point of the bill. The bill will allow experts in the field to make knowledgeable and scientifically based assessments of the safety of the drug. The argument that passage of this bill will increase the number of abortions in Australia is hard to counter because by definition we have no Australian data to consider. However, experience in countries where medical abortion is available suggests that the availability of medical abortion does not increase the overall rate of abortion.

I would like to point out another matter which is not often raised. RU486 can be used in the treatment of a range of conditions, including inoperable meningiomas, endometriosis, fibroids, metastatic breast cancers and bipolar disorder. This is a side of the current laws which is not often highlighted. The effective ban on RU486 has denied this drug to people who may want to use it for purposes other than bringing on an abortion. One constituent has contacted me because she has severe endometriosis. Her doctor advises her that RU486 is probably the only option she has available to her now. In her case the disease has progressed beyond the point of being able to be operated on. She is very keen to see this drug made available to her and to others in her situation.

I would like to thank all those people in Isaacs who have contacted me about this bill. I know that by supporting this bill I have not followed the wishes of some of my constituents but that I have followed the wishes of others. I know that there are strong and genuinely held views on both sides of this debate. I have read and responded to all the emails and letters from those in Isaacs. I have had a number of telephone conversations with constituents who hold views on both sides of this debate, and I hope and I am sure that these conversations will continue. No-one has the monopoly on wisdom and we all have to weigh up the arguments and come to a decision. I have tried to make my decision carefully and honestly and after listening to the arguments for and against. I will be rejecting the amendments that have been proposed and moved to this bill, and I will be supporting this bill.

Peter Slipper (Fisher, Liberal Party) Share this | Link to this | Hansard source

At the outset, let me say that I am opposed to the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. I see the current situation as being the most desirable situation. However, I would be prepared to support the amendment moved by the honourable member for Lindsay and, were that to fail, I would support the amendment proposed by the honourable member for Bowman.

I oppose this bill on a number of grounds. Firstly, I believe that the drug RU486 is medically unsafe and unproven. Secondly, I believe that as elected representatives we do have an obligation to play a role in making decisions on issues of great moral importance. Thirdly, on a personal note, I am opposed to abortion.

I congratulate all of those honourable members who are participating in this debate, regardless of the position they are individually taking, because by having a conscience vote on an important issue such as this we are proving that the parliament of Australia is working and that we are able to come along here and think through the issues. While we might on occasions—and undoubtedly we will on this occasion—reach differing views, I think we are all being honest. The Australian community would expect each of us to be honest, to think through the various issues and the ramifications of our vote and to make a decision accordingly.

The issue of RU486 has been described as a number of things. It has been described as a moral issue, as a religious issue and as a policy issue. At this stage in the debate I have been extraordinarily disappointed by how some members have been targeted because of their religious faith. The Minister for Health and Ageing  is a person of very high principle, as are others on both sides of the House. I do not believe that contributions to this debate or how one is going to vote ought to be publicly based on whether or not one is a member of the Roman Catholic Church. This drug, RU486, is a life and death issue and for that reason the power to approve the drug in Australia in my view should remain with the minister for health. It has been this way since 1996 and no-one objected when Minister Wooldridge had that responsibility nor when Minister Patterson had it.

Statistics from those countries that already allow the use of RU486 show that between one in 20 and one in 12 women who are administered the drug will require urgent post-abortion care. Common side effects include considerable bleeding, surgery and, in some cases, the need for blood transfusions.

But there should be more concern over the number of deaths of women as a direct result of taking RU486. There has been a figure mentioned of five fatalities around the world as a direct result of taking RU486. From research on the internet, it appears that there have been deaths in Britain, France and the United States since the drug first became available some years ago. Personally, I wonder if the actual death rate could be higher.

Once taken, RU486 must be followed up two days later with a second drug, Cytotec, commonly known in Australia as misoprostol, which is the clean-up drug. A story under the headline ‘No Magic Pill’ on the US website National Review Online noted:

... when taken alone, RU-486 causes a complete abortion only about 60 percent of the time, leaving a patient vulnerable to serious infection and hemorrhaging.

The follow-up drug, misoprostol, triggers contractions in the uterus, with the specific purpose of expelling the baby to be aborted, thereby reducing the chance of deadly infections. But this drug also comes with a significant risk of complications. This drug was never designed to be part of a ‘killer couple’ in chemical abortions. This drug was actually designed to treat stomach ulcers. Side effects of misoprostal can include reduced blood flow to the uterus, possible rupture of the uterus—requiring surgery to repair the damage or even a hysterectomy—severe pelvic pain, retained placenta, severe genital bleeding, shock and, in the worst cases, death. It is no wonder that the silent partner of RU486 in this debate comes with the following warning from its manufacturer, Pfizer:

We would not recommend use outside TGA-endorsed indication and at this stage that just involves stomach ulcers.

That is a quote from the Australian of 31 January this year. Perhaps there should be an investigation into the availability of this drug to aid the abortion of unwanted babies. With regard to the deaths resulting from infection caused by the unsuccessful use of RU486, one commentator noted that they may go down in the records as being unrelated to the drug itself. I quote nationalreview.com of 26 September 2003:

... RU-486 did not cause the septic shock which killed a woman taking part in Canadian drug trials. And that’s technically true, of course. The infections are caused by dead human embryos or parts thereof which are not fully expelled.

It is difficult to ignore the emotion associated with this issue, because it involves the termination of life. I personally believe that life begins at conception. That is a personal view that I have. The predominant argument by those supporting the provisions of this bill has been that the approval of such a drug should not be left in the hands of a politician—that the decision on what is essentially a medical issue should be left up to those with medical expertise, such as those in the Therapeutic Goods Administration. The opposing view—the view I hold and that I enunciated a moment ago—is that those who are elected to parliament are thereby given a mandate to make tough decisions. This is particularly important given the type of risk documented in chemical abortions using RU486 and misoprostol in combination.

The minister for health does not make decisions based on whim. He would receive advice from the professionals involved in the Therapeutic Goods Administration and other sources before he would ultimately come to a decision. It is wrong to say that the minister is not qualified and that he does not act on advice. He certainly would never make a decision without taking into account all the advice before him.

It is important that elected members listen to their constituents and take the public’s views on board before making a decision on how they will vote. This is a very interesting issue. Like other honourable members, I have received a number of letters and phone calls at my electorate office regarding this issue, and overwhelmingly people have expressed their views against the legalisation of the RU486 drug. The people in my electorate office tell me—and I scrutinised and questioned them very closely—that we have not received one letter, email or phone call from a constituent in support of this bill. I find that amazing but it is actually the case. We have received no indications of support from people in the community. The majority of constituents express their stance based on moral grounds; others base their reasoning on both moral and medical grounds.

If I were to base my vote solely on the opinions of those constituents who have taken the time to contact my office about this issue, I would have no choice but to vote against this bill, because this bill would work towards the legalisation of RU486 in Australia. As I said, however, I have looked very carefully through the provisions of this bill. I have looked at the two amendments before the House. RU486 is a matter of life and death. The final decisions should be left in the hands of those who are in a position to balance the many varying opinions with the scientific facts, in order to come up with the right decision. I believe that the current situation is the ideal one, but I see the position advocated by the honourable member for Lindsay as being an acceptable compromise. The minister would make the decision; he would continue to receive advice from the Therapeutic Goods Administration; he would have to receive written advice from that administration prior to giving approval or refusal; and his decision would be subject to disallowance by each house of the parliament.

I respect everyone who has expressed views similar to mine and in opposition to mine. This is a very healthy debate. I plead with my colleagues in the chamber to either reject the bill or support the amendment moved by the honourable member for Lindsay.