Thursday, 16 February 2006
Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005
Consideration in Detail
Bill—by leave—taken as a whole.
by leave—I move amendments (1) to (4) together:
(1) Schedule 1, item 1, page 3 (lines 4 and 5), omit the item.
(2) Schedule 1, item 3, page 3 (lines 8 and 9), omit the item.
(3) Schedule 1, item 4, page 3 (lines 10 and 11), omit the item, substitute:
4 Section 23AA
Repeal the section, substitute:
23AA Evaluation and registration of restricted goods
(1) Subject to this section, restricted goods may be evaluated and registered in accordance with the provisions of this Division as they apply to therapeutic goods.
(2) In spite of any provision of this Division, if the Secretary’s decision under paragraph 25(4AA)(d) is to register restricted goods, the Secretary must as soon as practicable notify the Minister of the decision to register the goods.
(3) The notice under subsection (2) is a legislative instrument.
(4) The registration of restricted goods must not take effect before the expiration of time within which a House of Parliament may disallow the instrument.
(5) If the instrument is disallowed or deemed to be disallowed under section 42 of the Legislative Instruments Act 2003, the decision that the Secretary made ceases to have any effect.
(4) Schedule 1, page 3 (after line 13), at the end of the bill, add:
6 Subsection 25(4)
After “therapeutic devices”, insert “and are not restricted goods”.
7 After subsection 25(4)
(a) the therapeutic goods are not therapeutic devices and are restricted goods; and
(b) the evaluation of the goods for registration has been completed;
the Secretary must:
(c) notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and
(d) if the decision is to register the goods:
(i) notify the applicant in writing that he or she has notified the Minister under section 23AA; and
(ii) after the expiration of time within which a House of Parliament may disallow the instrument, and subject to disallowance of the instrument under section 23AA:
(A) notify the applicant in writing as soon as practicable that the goods will be included in the Register if the applicant gives the Secretary the certificate required under subsection 26B(1); and
(B) include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary the certificate required under subsection 26B(1).
To avoid doubt, subject to disallowance of the instrument under section 23AA, if the applicant gives the Secretary the certificate required under subsection 26B(1), the Secretary must include the goods in the Register under subparagraph (d)(ii) without inquiring into the correctness of the certificate.
I mean no disservice to the great civility, the grace and the thoughtfulness with which we have participated in this debate over the last 2½ days. But as a person of scientific training I put it to you that this question is no longer just science, and I summarise the amendments that I put to the chamber today as follows: if there is in the mind of every member in this place no doubt that RU486 is just another medication, then you will strike down my amendments. If it is your view that the laws we have for abortion in every state are immutable and that everything within those laws, everything that subscribes to those laws and is simply added to the menu of options for women, will never change, then you will strike down my amendments. And if you believe that there is no counter to that libertarian view that every individual, given the right information, can simply work their way through all the information and make an informed decision, that there is no need for a corridor of tolerability in the social services we deliver and that government has no role in that, then you will strike down these amendments.
But, more importantly, we will uphold first and foremost that the Therapeutic Goods Administration is unimpugnable in its efforts to analyse the science. The debate is not about the science. We move beyond that with these amendments. But it is vital that the analysis of science never trumps the option to consider more detailed views in this place, and that is why many of us left our professions to come here and consider just those issues and never walk away from them, never avoid the truly tough decisions that we believe in our own hearts to be right. The unintended consequence of this bill is that it strips away that final look at decisions made by well-meaning, highly educated and expert bodies—and I list the TGA among those. This is an issue of science and then some, and we simply cannot airbrush away those extra issues. I do not share the views of the extremes of both sides of this debate, but I will fight for those views to be heard after we have had an informed debate.
We have had an informed debate using overseas information filtered to us through different agencies but never—and this is a good thing in this bill—has that evidence been taken to the TGA. When it comes through, it will most likely recommend this drug as safe and this drug will come here and probably not be stopped by the proposals I recommend. They will go through both houses without a disallowable instrument ever being effective in stopping the drug. So do not mistake my actions today as an effort to scuttle RU486. Do not mistake my view, either, as one to complicate the debate. I stand here purely to leave that option open—to leave the option open for the tough decisions, through community views, to filter up here so that we do the things that we have, after all, been elected to do.
Isn’t it ironic that the very 2½ days of energised debate we have had, without my amendment, will become impossible in the future? This amendment is about having the option to come back and do just what we are doing today. I take no pride in the fact that we keep the issue of abortion out of this chamber. We have managed to do it for decades on end and we think it is not something we want to raise here—it is too venomous and too difficult to resolve. That is not the attitude that we should be taking. Nor should we view this as just another pill—that is completely obvious. One hundred and thirty-seven of us have come down here in a conga line to express our feelings one after the other for 2½ days.
So let us not fool ourselves that RU486 is anything as simple as a general therapeutic to be decided by an expert body. This is a medication; we know the mechanism of action and it raises great concerns with some. I am not asking us to adjudicate upon this as experts; clearly we are not. The TGA are the scientific experts aiding the women in this terrible predicament when they have to make these tough decisions. They have the frustration of infertility, to which we dedicate enormous efforts and resources. But, in the end, it is the community that sets what we do. It is not left to an expert body. So cast this not as politicians stepping into bedrooms nor parliamentarians stepping into consulting rooms. This is done with embryonic stem cell research and with therapeutic cloning. It is done in every state House when these tough decisions on abortion come back to parliament. I have argued that the use of a disallowable instrument is the best of the three options we have. One is to live with tough decisions; one is to use a disallowable instrument; and one is to legislate every time this question arises.
I rise to reject the amendments moved by the member for Bowman. We have already rejected the amendment moved by the member for Lindsay, which did not change the status quo. Sadly, the amendments by the member for Bowman do not change the status quo, which has now persisted for more than 10 years. In 10 years, not a single pharmaceutical company has applied to have RU486 evaluated because the 1996 Harradine amendment politicised the process. His amendment exchanged the scientific evidence based evaluation of the drug by the TGA with a unilateral decision by the health minister of the day.
It is not our task as elected representatives in this place to decide by what medical method a woman is given a pregnancy termination by her doctor. If we followed such logic to its conclusion we would be deciding by what surgical method a termination was performed. That is not our task as elected members in this our great democracy. Why? It is because abortions are a lawful procedure under certain circumstances in every state and territory, and that debate was settled some 30 years ago. This debate is not about women’s access to terminations. All of us would prefer, of course, fewer unwanted pregnancies and all of us, because of the personal trauma that is associated with having to have a termination, would want to work towards reducing the factors that lead to unwanted pregnancies. But this bill is not about better sex education and counselling. That is a debate for tomorrow. Nor can we ever accuse this parliament under our leadership of shirking any difficult decision.
The bill being debated here today ensures that our parliament can again be assured that Australian doctors have the safest and best possible options available to help women patients who need to have a termination. It is as simple as that. The Laming amendments continue to politicise the decision about what the TGA recommends as the best, most safe options available to doctors. For example, we now have before the government three requests for approval of RU486 for use by individual doctors for their own patients. These three applications were lodged last December when the clinics saw the process had a chance of being returned to scientific assessment.
Under the Laming amendments, each of these cases would be brought before the parliament and you could virtually guarantee they would be debated, even if the TGA had approved their applications. Ultimately, you would expect those debates to end up with the right outcome, but they would, I am quite sure, make our pharmaceutical companies in Australia think twice about trying to have a general application for this drug brought before the TGA. I repeat: it is not our political task to assess the safety of this or any drug. The TGA are amongst the world’s best and were set up to handle the evaluation and monitoring of all drugs in Australia. It is their business. We need to reject these amendments, well meaning as they are, and simply get on with the job.
I was appalled at the statements by the Leader of the Opposition. He made them very definitively. He said that the Prime Minister should not have appointed a person to this portfolio who had certain beliefs. He then proceeded to use the example of appointing a pacifist as defence minister. My mind immediately leapt to the fact that one of the ALP’s greatest ever leaders, their war leader—Curtin—was a very avowed pacifist. Most people in Australia, the vast bulk, would say that he made a very good war leader. The sectarian nature of the attack upon the minister appalled me. I asked for the Hansard because I did not believe that he said it, but, if there was any doubt in anyone’s mind, he went on to give an example. So Kerry Nettle’s T-shirt lives on in this place. The Hansard speaks for itself.
I am loath to do so, Mr Speaker, but I rise on a point of order. The stage of the debate we are in at the moment is addressing the amendments moved by Mr Laming, the member for Bowman. These remarks are not in any way relevant to that question.
I rise to support the amendments moved by the member for Bowman. In principle, this is because I recognise—and I commend this to the chamber—that the debate on the bill that is before the chamber today is more than merely a debate on the safety and efficacy of RU486. It is more than merely a debate about saying whether or not we as a parliament can delegate authority to the TGA or whether we as a parliament can rely solely on the advice of the TGA when it comes to restricted goods under the Therapeutic Goods Act. Much more than this, the reason the member’s amendments should be supported—the reason an amended bill should go through the chamber—is that the fact we have had 2½ days of debate on this topic underscores the fundamental importance and recognition in the Australian community that this debate is about more than safety and efficacy.
There is a third dimension to this debate, and that is the question of morality in these kinds of debates. In saying that, I hasten to add that I am not someone who is seeking to impose my personal viewpoints on others—quite the contrary. What is clear from survey after survey throughout the Australian community is that Australians—irrespective of whether they are Christian, Muslim, atheist or agnostic—hold very strong views on the issue of abortion. The simple fact that there are strong views highlights the fact that this issue embraces so much more than merely a consideration of safety and efficacy, particularly with respect to RU486.
So if we accept the notion that there is more at stake than merely the safety and efficacy of RU486 and that there is this third issue dealing with the morality of these kinds of drugs and dealing with the fact that in the future we can expect there to be an increasing encroachment on moral and ethical issues with respect to restricted goods as science develops them further, then surely there is no better place than the floor of this parliament for us to consider whether or not we wish to have these kinds of drugs imported, legalised or restricted in any particular way by the TGA.
I readily admit that the structure of the current bill is flawed. I indicated that in my speech last night. But we now have before us an opportunity to correct that flaw. We now have before us an opportunity to make an informed decision whereby this parliament can take the very best advice offered to it by the TGA and then put it in a much greater and more detailed matrix—one that looks at those other considerations and does not merely say that the only issues here are safety and efficacy.
If we do only that it will be a sell-out for the Australian people. We could say to them that we are doing this because those who are opposed to the bill as it currently stands do so because they seek to impose their will on others, but that would be untrue. This is not about the imposition of any particular religious faith. This is not about whether or not the minister for health happens to be a Catholic. This is a fundamental decision that is underwritten by the Australian people, who have indicated their very strong views that abortion needs to be debated and that we as representatives of the people must exercise the will of the people by making these decisions come back to us to incorporate that third element. Certainly, no-one would argue that safety and efficacy considerations are best left to the TGA. This bill in no way undermines the ability to do that. But to deny that there is this third element—a third consideration—is to close one’s eyes to the fact that, irrespective of background, all Australians know that there is this third element to be considered.
I strongly urge all members to get behind the amendments moved by the member for Bowman. They are considered amendments. They enable us to take the very best advice from the TGA, but also ensure that supreme in the decision making is the will of the Australian people. We, as representatives of the Australian people, should be the final arbiters on these very facts.
I rise to speak against the amendments moved by the member for Bowman, though I believe he has moved them in extreme good faith and has argued very well for them in this place. The amendments before the chamber, and indeed this bill, are not, in my view, about the legality of abortion. That has been decided elsewhere in this country in the parliaments of our states and territories. It has been inevitable that in the course of dealing with this bill in the chamber people have made comments about their attitude toward abortion, and I understand that. Many members, including the minister for health, have adopted the Bill Clinton terminology that they would like to see a circumstance where abortion was safe, legal and rare.
I agree with those comments. We would all like to see a circumstance where abortion was safe, legal and rare. But we need to be honest enough to say that that is not about parliamentary oversight and disallowance motions. If we were to truly live in a world where abortion was safe, legal and rare then we would need to live in a world where there was no sexual violence against women. We would need to live in a world where no woman was ever bullied or pressured into having sex. We would need to live in a world where the mass media did not continuously say to women that the sum of their self-worth was defined by their sexual desirability to men. We would need to live in a world where contraception never failed. We would need to live in a world where people understood how to use contraception. We would need to live in a world where medical science had defeated some of the most profound and disabling birth defects.
I wish we lived in that world, and we should all be striving to attain it, but the stark reality is that we do not. When we do not live in that world it is inevitable that women from time to time—many with the heaviest of hearts—will exercise the decision to have an abortion. What we are debating today is no more than this: when they make that choice within the legal frameworks of the states and territories in which they live, should they have an option other than surgical abortion, provided that medical experts say that is safe and effective? I say that they should.
I am pro-choice—I strenuously object to the terminology ‘pro-abortion’; I have never met anybody who is pro-abortion and I am not. I understand that those who have a different view about abortion to mine—those who are not pro-choice—might be concerned if there was evidence that the availability of RU486 increased the abortion rate. There is no such evidence. If you look around the world, there is no such evidence that RU486 increases the abortion rate. Whilst I respect the moral compass of those who do not believe in choice, I do not understand a circumstance where people say ‘morality lies in the method’. That is what I think we are looking at today. I do not see why people should say there is a moral difference between surgical abortions or medical abortions. I do not see how that can be put.
The amendments moved by the member for Bowman would cause, if the TGA decided that RU486 was safe and effective, a disallowance debate on that. It would be inevitable that one member of this House and one member of the Senate, if not more, would move for disallowance. Let us just imagine that we were having that disallowance debate. Is anybody seriously suggesting that people would be coming up to the dispatch box and putting more expert views on the question of safety and effectiveness than the TGA had? No. People would be coming up to this dispatch box and putting their views on abortion. I do not think a disallowance procedure should be set in law which would mean that we refight the abortion debate inappropriately in this parliament time after time. I do not think that is right.
I also think if these amendments were passed we would have an effective ban because no manufacturer would seek to put RU486 to the TGA for a safety and effectiveness assessment and spend all the money to get that done if they were then going to face the political vagaries of this place. It is on those grounds that I ask people to reject these amendments. I respect the fact that they were moved—I think it is good that we have canvassed the issue—but, ultimately, they are not acceptable, they should be rejected and we should vote for the bill.
I also wish to speak against the amendments of the member of Bowman. The amendments were moved in good faith, and I respect the member for Bowman. The amendments would not only defeat the purpose of the bill, allowing political interests to outweigh medical and scientific advice, but also magnify the existing uncertainty surrounding this drug. This uncertainty would almost certainly guarantee that no sponsor company would apply for importation and distribution of RU486 in Australia. In the unlikely situation of a company or companies applying, every application for RU486 and other abortifacients evaluated by the TGA would need to be again debated by this parliament. I respect every member who has contributed to this debate, but I do not think we need to repeat the arguments over and over. I urge all members to vote against these amendments.
I wish to make three simple points in support of the Laming amendments. The first is that I believe, for those who wish to maintain the status quo, they should support these amendments because they preserve the sovereignty of parliament. On the alternative side, for those who would prefer change—and I respect and actually agree with the position outlined by the member for Lalor that the essential question in this debate is whether or not a new class of termination be made available to Australian women, that is, the class of medical termination—these amendments do not prevent that. It means that the ethical decision we take is not before the TGA makes its decision, which is what we are doing if we vote yes now, but afterwards.
Why is that important? It is because the TGA (1) sets out its medical opinion, which I think it is consistent for this House to look at, but (2) sets out conditions for use. As somebody who supports the extension of the right to medical termination through the use of RU486, I believe that the appropriate time for the parliament to make the ethical decision is after the TGA has provided its information and set out the conditions in which it would apply. On either account, we are making an ethical decision, because if we decide yes now we are making the ethical decision that we give in-principle support for medical termination, if the TGA agrees. Alternatively, we would also be making an ethical decision but an ethical decision which says, ‘Given that the TGA has made its decision, we now give our ethical support but we do so on the basis of the best advice in Australia and the available conditions.’ So I respectfully disagree on that point.
The final point on which I wish to respectfully disagree with all three speakers who have spoken against the amendments is the ‘time after time’ proposition. That is the notion that we would face a series of disallowance instruments over coming years. With great respect, that is a misconstruction of the bill and contrary to the information I have. It is a misconstruction because we would be called to decide not upon the circumstances of individual applications but upon a generic TGA application. The best advice I have is that, on the pipeline of abortifacients and their likelihood of being brought to Australia, this chamber is likely to face one disallowable instrument over the coming five years. I repeat: on the best advice I have available, it is not a question of ‘time after time’; it is one decision that is likely to be faced over the next five years because none of the other possible drugs is likely to be brought before the TGA for an application. For those reasons, I strongly support the Laming amendments.
I rise to urge support for the amendments moved by the honourable member for Bowman and to plead with those people who voted to give the bill second reading approval to consider that the amendments of the member for Bowman actually incorporate what they principally want to achieve through the passage of this bill. The first part of the explanatory memorandum points out that this bill is designed to repeal ministerial approval and to leave approval with the Therapeutic Goods Administration over access to RU486. It goes on to say:
The purpose of this bill is to remove responsibility for approval for RU486 from the Minister for Health and Ageing and to provide responsibility for approval of RU486 to the Therapeutic Goods Administration.
The amendments currently before the House pass that responsibility to the Therapeutic Goods Administration while also reserving to the House the opportunity, were the House to agree, to disallow that determination by the Therapeutic Goods Administration. These amendments enable honourable members on both sides of this debate to vote for them with a great sense of confidence and a great sense of comfort, knowing that the situation which will result in the event of the enactment of these amendments will be much better than the situation were these amendments to be defeated. Similarly, those members who opposed the second reading of the bill could vote for these amendments with confidence, knowing that the Parliament of the Commonwealth of Australia will have a right to debate, if the parliament so desires, a determination of the Therapeutic Goods Administration with respect to RU486.
I believe that the member for Bowman’s amendments are worthy of consideration, even by people who were very strong proponents of the bill in its unamended form. I plead with people who support the bill in its original form to consider that the amendments moved by the honourable member for Bowman enact what they want to see while still reserving to the people’s representatives in both houses of the parliament the opportunity of expressing a view.
The people of Australia elect us to make decisions on their behalf. I would be the first to admit that, as elected representatives, we cannot be technically expert in every aspect of medicine or every aspect of law. The proposal put forward by the member for Bowman recognises the primacy of, I suppose you would say, the scientific knowledge of the Therapeutic Goods Administration while also reserving to us, the representatives of the people, the opportunity to pass a view in the event that either house of the parliament might not agree with the decision of the Therapeutic Goods Administration. I commend the amendments to the House.
I want to encourage the parliament to see an opportunity today to arrive at something approaching a consensus view on this bill. We have that opportunity. I am one who did not support the bill when given the opportunity during the second reading debate. A lot has been said about the bill. Speakers from all perspectives have had their say on it. And do you know what? We are all respectful of our representative democracy—our parliamentary representation.
We would be mugs if we did not accept the outcome of this vote, which very clearly will be to see the passage of the bill through the parliament. I may not be very happy about that; I may prefer that it fail. However, in good faith, what anyone of us can do is to least accept the outcome. The verdict of this chamber will be that the bill, either amended or unamended, will pass this chamber—hopefully amended—and returned to the Senate to be ratified.
But let me ask this: why don’t all the speakers who have begun their speeches by saying ‘I respect the view of others’ put that into practice and show some respect for the people who, in good faith, have put up an amendment which basically seeks to deliver the broad outcomes of the bill, which is the repeal of any ministerial involvement in the approval of an abortifacient drug? Show some good faith. In fact, both the Kelly and the Laming amendments sought to give some ground in good faith.
We are now only debating the member for Bowman’s amendments. I think they show good faith; they give some ground. Equally, it has to be said that not one member who has spoken against the Laming amendments has been willing to concede the point that abortifacients do amount to a different and separate class of drug—not one. Why can’t we hear somebody acknowledge—if you are not a fundamentalist on this issue then please acknowledge—that a drug which does not have a therapeutic use, a drug which does not actually cure a medical disease, should be treated differently?
This is not a difficult intellectual argument. If you are not an ideologue, if you are not a fundamentalist on this issue, then please take some sense from this. Equally, if this is not in any way linked to a moral issue then why are we having a conscience vote? Why have our respective party leaders recognise that this is not just about process, that there is more to this issue than just expert advice?
With great respect, the Minister for Workforce Participation said that it is not our political task to assess the safety and efficacy of medicines. I absolutely agree. That is quite true. The purpose of the Laming amendments is not in any way to molest that concept. In fact, one of the Laming amendments supports what the minister has said but adds a further dimension by recognising that members of the TGA are not appointed on the basis of their ethical background or ethical expertise.
To say that this class of drug should be the domain of only scientific experts is greatly disrespectful of parliamentary democracy. I am prepared to concede that to say that the TGA is not able to provide advice is disrespectful to science and to the Public Service. I ask this chamber to again consider whether it is fair and reasonable to obtain consensus on this issue. We can deliver it. We can send a message to the Australian people that we believe that the parliament has an important role in assessing the future use of these drugs while, at the same time, accepting expert medical advice where that is appropriate.
I urge all my colleagues and others involved to show good faith, to give some ground and to acknowledge that we have an opportunity to achieve consensus on this issue. So I beg you, I urge you, to support the Laming amendments.
That the amendments (Mr Laming’s) be agreed to.
Bill agreed to.