Thursday, 9 February 2006
Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005
Before we proceed to formal debate, at about one o’clock, before the committee reported progress, a question was asked by Senator Lyn Allison about the arrangements for the procedure during the committee stage. Can I assume, with respect to the running sheet that has been circulated, that people have a copy of that and that it reflects any agreement? Has the running sheet been circulated?
I have one. Being the only one that perhaps has one, I will let you know, as the mover of the first group of amendments with Senator Humphries, that we have agreed to split the time with Senator Colbeck and Senator Scullion.
The question asked by Senator Lyn Allison of me was whether I would set times. I made it clear that it was not within the province of the Chairman of Committees to set times, that that was normally done in a standard debate by arrangement between the parties. Then I made it clear that I hoped that the parties would go away and come to an arrangement. I was hoping I might get something in writing out of the interested parties; I am obviously not going to get something in writing. That was too much of an expectation on my part. Can I get direction?
It is my understanding informal arrangements have been made between the parties regarding the limited time we have and that that has been negotiated between the speakers who are moving the series of amendments and also the people who are speaking to them.
I will rely on the goodwill of the people involved in the debate in keeping to the time. You must understand I have nothing in front of me and I can only guide the business of the committee. Is there anything else before I start on the running sheet that I should know about the progress of this bill during the committee stage? As I understand it, so that there is no misunderstanding, the motion already adopted by the Senate means that the debate on the committee stage will be completed at 4.25 pm.
I wish to advise you that the informal arrangement was that we would split the time evenly between the first group of amendments from Senator Barnett and Senator Humphries and the second group from Senator Colbeck and Senator Scullion and that the ‘for’ case and the ‘against’ case, if you like, would also be given equal time.
Given that I can only set the time in accordance with normal standard practice and procedure, I do not know what times will be available. But I will endeavour—I think I know who is on which side of the debate—to call people in the debate.
In terms of the senators for and against, I was of the understanding that the movers of the amendments were to speak to them and argue them. I was not clear if there was an understanding that that time would also be split between the proposers and those against. I assume you will have time at the end to wrap up your arguments against. Senator Nash might be able to clarify things.
I have to manage this and I respect the arrangements that have been put in place, but I will deal with the running sheet as presented. It seems to me that by doing that we will deal with the Barnett-Humphries amendments, if I can put it that way, and we will obviously allocate half the time, which according to me is roughly 35 minutes, to each case—so, about 17 minutes each. So we have 17 minutes allocated to the first lot. Is it the desire of the committee that we vote on the motion at the end of the first debate or will we vote on everything post 4.25 pm?
My understanding was that the first lot of amendments, put forward by Senators Barnett and Humphries, would be voted on at the end of that, and then we would move onto the second lot of amendments and then they would be voted on at the end of that. The 17-minute split—I understood the time was to be halved between the for and the against cases.
by leave—I move Barnett-Humphries amendments (1) and (3) to R(8) on sheet 4828 revised together:
(3) Schedule 1, page 3 (after line 13), at the end of the bill, add:
6 After subsection 6AA(2)
(2A) Before giving written approval in accordance with subsection (2), the Minister must:
(a) seek written advice from the Australian Health Ethics Committee; and
(b) consider that advice; and
(c) prepare a written statement of reasons for the approval or refusal to approve the importation.
(4) Schedule 1, page 3 (after line 13), at the end of the bill, add:
7 After subsection 6AA(2)
(2B) The Minister must give written notice to a person seeking approval in accordance with this section of the approval of, or of the refusal to approve, the importation.
(5) Schedule 1, page 3 (after line 13), at the end of the bill, add:
8 Subsection 6AA(4)
After “approval”, insert “together with the written advice received by the Minister from the Australian Health Ethics Committee and the written statement of reasons by the Minister for the approval of, or of the refusal to approve, the application”.
R(6) Schedule 1, page 3 (after line 13), at the end of the bill, add:
9 At the end of section 6AA
(6) A written approval or refusal to approve in accordance with this section is a disallowable legislative instrument for the purposes of the Legislative Instruments Act 2003.
(7) Where the Minister issues a written refusal to approve an importation and that instrument is disallowed pursuant to subsection (6), the importation of the restricted good to which the instrument referred is taken to be approved by the Minister.
R(7) Schedule 1, page 3 (after line 13), at the end of the bill, add:
10 Subsection 23AA(2)
Repeal the subsection, substitute:
(2) Before giving written approval in accordance with subsection (1), the Minister must:
(a) seek written advice from the Australian Health Ethics Committee; and
(b) consider that advice; and
(c) prepare a written statement of reasons for the approval or refusal to approve.
(3) The Minister must give written notice together with the statement of reasons for the approval of, or for the refusal to approve, the evaluation, registration or listing of restricted goods in accordance with this section.
(4) A written approval, or refusal to approve, the evaluation, registration or listing of restricted goods shall be laid before each House of the Parliament by the Minister within 5 sitting days of being given.
(5) A written approval or refusal to approve in accordance with this section is a disallowable legislative instrument for the purposes of the Legislative Instruments Act 2003.
(6) Where the Minister issues a written refusal to approve the evaluation, registration or listing and that instrument is disallowed pursuant to subsection (5), the evaluation, registration or listing of the restricted good to which the instrument referred is taken to be approved by the Minister.
R(8) Title, page 1 (lines 1 and 2), omit “repeal Ministerial responsibility for approval of RU486”, substitute “provide conditions for the exercise of Ministerial responsibility in relation to certain therapeutic goods”.
The intent behind these amendments is to take on board the views that were put to the Senate committee of inquiry as well as some of the views expressed during the speeches in the second reading debate. The amendments are designed to improve the process for approving an abortifacient or other drug on the restricted goods list.
There are three main objections that were expressed during the inquiry and by a number of senators in their speeches in this place that I wish to acknowledge. Firstly, they said, ‘Why just the minister? Why not the parliament? Why isn’t there parliamentary scrutiny of the decision by the minister? As members of parliament we are accountable and responsible to our electors.’ Secondly, they wanted to know: ‘Where does the minister get his advice from? From where does it come?’ Thirdly, they objected to the fact that the text is ‘the minister lays on the table of both houses of parliament notification of his approval,’ not ‘his approval or disapproval’. Also, under the current arrangements, as senators are aware, the minister is not required to state his reasons when he provides that notification.
I want to acknowledge that during the debate Senators Payne, Stott Despoja and Conroy noted that our amendment—that was the first amendment put out, the one distributed last night—referred to the tabling of only the minister’s approval. You will see that the amendment before you refers to tabling of both approvals and rejections of approval by the minister. So that particular point has been addressed and I acknowledge the work of those senators. I also want to thank all senators for their efforts during this debate. It is emotionally draining, as it was for the senators who were involved in the committee inquiry. It is a conscience vote, which is unusual, and that is one of the reasons why we are standing here today.
Those are some of the inadequacies in the current process. We want to improve that, so what Senator Humphries and I have suggested in these amendments is that, before the minister gives written approval or disapproval of the drug, the minister must seek written advice from the Australian Health Ethics Committee. And I have details on the Australian Health Ethics Committee: it is a principal committee of the NHMRC; its membership is specified in the act; it consults extensively with individuals, community organisations, health professionals and governments; and it undertakes formal consultations on these sorts of very important moral and ethical issues. So the minister must take that advice. He must seek that advice and consider that advice and then prepare and table in both houses a written statement of the reasons for the approval or the disapproval of the drug, along with the Australian Health Ethics Committee advice.
So the minister’s decision, whichever way it goes, would then be subject to disallowance by either house of parliament. I think this really addresses a key point that has been raised over the last few weeks and in the last 48 hours with regard to this debate. It says that the ultimate say-so is with the people in the federal parliament—in this chamber and in the House of Representatives. A lot of people have said that the Minister for Health and Ageing, Mr Abbott, has certain strong views about abortion; well, in years to come there may be another minister who has perhaps pro-abortion views or totally different views. We accept that. The point is that the ultimately say-so rests with the members of this parliament. That is because the licensing and management of abortion drugs does not just raise health issues. Yes, the health issues must be addressed by the TGA—the safety, the quality and the efficacy of the drug. That is entirely appropriate. But the community, social and ethical issues must be addressed by the parliament. We believe this suggestion will improve the process.
So I have explained the process and our recommendations about it. I did just want to make an observation with regard to Senators Colbeck and Scullion’s amendments. It appears from the amendment that I have seen that there is an omission with respect to section 6AA, referring to the import of the drug. There are two types of decisions that can be made by the minister: one relates to the evaluation, registration and licensing of that particular drug; the other relates to the importation of the drug. There are two separate processes. Our amendment addresses both, and the minister’s decision on either is disallowable in the parliament. Under the amendment circulated by Senators Colbeck and Scullion, it appears that that second approval process for the importation of the drug is not there, so I just draw that to the senators’ attention. I think that sums it up and I would like to leave time for my co-sponsor of the amendments, Senator Humphries, to make some comments.
I would like to respond, on behalf of the sponsors of the bill, to the amendments that we are looking at—that is, amendments (1) and (3) to (8) on sheet 4828. On the surface these amendments respond to some of the criticisms of the current arrangement, but when you look at them in detail they are little more than tinkering around the edges and, indeed, they place further hurdles in the way of assessment and approval of RU486.
Amendments (1) and (8) simply change the title of the bill and they require no comment. Amendments (3) to (5) put in place further requirements on the health minister in relation to applications to import RU486. Amendment (3) requires the minister to seek the advice of the Australian Health Ethics Committee before approving the importation of any restricted good. Amendment (4) requires the minister to let the applicant know whether their request has been approved or not, and amendment (5) requires the health minister to provide the parliament with a copy of the advice from the Australian Health Ethics Committee, along with a statement of the minister’s reasons for approving or rejecting an application to import RU486.
Amendment (6) makes any decision by the minister to allow or not allow the importation of RU486 disallowable. Amendment (7) puts in place similar requirements on the health minister in relation to applications to evaluate, list or register RU486, just as I have outlined for the importation. That is, the minister must seek the advice from the ethics committee, provide parliament with a written approval or refusal and so on.
There are many, many problems with what is being suggested. Firstly, the minister still has, in the first instance, the power—on his or her own—to approve or disapprove any application to evaluate, register, list or import RU486, and there are still no specified criteria that must be used. It is unclear what the purpose of involving the Australian Health Ethics Committee is. If that committee is supposed to comment on the safety and efficacy of RU486, how is this committee better qualified to do this than the TGA? And, of course, the minister still does not have to follow the advice; it just has to be considered.
The Senate might consider this: in amendment (6) it would seem that, if the minister refused an application to import RU486 and this was overturned by the parliament, then RU486 would automatically be allowed to be imported without the TGA having any chance to evaluate its safety. In amendment (7) part (3) it is unclear who is getting the written notice—the parliament or the applicant. If it is the applicant, there seems to be no way that the parliament gets a statement of the reasons behind the minister’s decisions. And finally—and this is probably the key issue—making the approval notice disallowable still leaves the key problem that decisions on the use of RU486 are left to politicians who are not experts on the safety and efficacy of RU486, and it still leaves the TGA and their expert advice out of the approval process.
This morning I listened to Senator Stephens recite what I am sure she believed was expert scientific advice. Those of us on both sides of the debate, if we were to go through this process proposed by Senator Barnett, could equally gather volumes of scientific advice in order to put our case—and who would know whether we were right? Nobody would know; no individual member of parliament, or a subgroup of parliamentarians or the parliament as a whole has the necessary skills, knowledge or resources to evaluate the safety of a drug. This is what this debate is about. The TGA is the group that should be making this decision, not parliamentarians or an ethics committee.
I want to make a contribution to this debate and support the amendment which Senator Barnett and I have moved. There has been comment in the second reading debate already about the choice that senators are being asked to make between a decision by the Therapeutic Goods Administration on the one hand, about whether this drug should be available in Australia, and a decision on the other hand by the minister for health—this individual who is supposed to make a decision in splendid isolation from those around him.
I suggested in my remarks the other day that that was a false dichotomy—that, in fact, no minister makes such a decision in isolation. However, it is clear from the remarks made by many in the course of this debate that some have been influenced by the suggestion that a decision by the minister for health, under the present arrangements, amounts to a decision by a single individual divorced from the sentiment or mood of the elected representatives of the federal parliament.
Let us therefore clarify that that is not what ought to continue. I have argued, as have most of the people against this legislation, that there needs to be parliamentary oversight of this process, that the decision to allow the use of this drug, RU486—or any other chemical abortifacient—in this country is a big decision, a momentous decision, and any other momentous decision made by and on behalf of the Australian community is made, not by unelected officials, but by the elected representatives of the Australian community. And that is why this amendment addresses that point and provides for a direct parliamentary vote on whether RU486 should be used in Australia.
It does not avoid the capacity for the Therapeutic Goods Administration to consider the efficacy and safety of the drug at another point in process. It does not exclude that capacity, but it provides, in addition to that process, for there to be parliamentary oversight and a parliamentary vote.
It is a big question of our day. It is an issue on which the Australian people in very large numbers have turned to us with their opinions. We owe it to them to hear what they have to say, understand and contemplate the issues they raise and then cast a vote based on the things we understand they say and our own particular judgments about the matters at hand. We owe that to the Australian people. That is our obligation as members of the federal parliament. For that reason we should support this amendment.
I have a question of the movers of the motion. I understand that the trans-Tasman agreement for harmonisation of therapeutic products is currently under negotiation between Australia and New Zealand and is going to merge the TGA and the counterpart New Zealand organisation. In recognition of some basic administrative differences between Australia and New Zealand, and, given the potential different approaches in some regulatory activities between the two countries, can the movers of the bill please explain what the effect of this is going to be, particularly in the light of the amendments now being raised?
It is my understanding that there is no effect at all. In fact, you could argue that there is a problem with our harmonisation, if you like, with New Zealand in that, under our arrangements, abortifacients have to go through the current process of veto by the minister whereas in New Zealand this is not the case.
In answer to Senator Fierravanti-Wells—I am relating back to my earlier experience in agriculture, where there were many discussions over co-arrangements with New Zealand—it is my understanding that each of the respective authorities would be subject to and belong to their own governments in that respect, irrespective of any international arrangements that were made.
That the amendments (Senator Barnett’s and Senator Humphries’) be agreed to.
I advise that there are some more amendments which will be moved on behalf of Senators Barnett and Humphries. I understand that there will be no division on those. They will be followed by the amendment by Senators Colbeck and Scullion and there will be a division, as I understand, at the end of that. We now proceed to the Barnett-Humphries amendment (2) on sheet 4828 Revised 1:
The question is that schedule 1 stand as printed.
Question agreed to.
I move the Scullion-Colbeck amendment (3) on sheet 4830:
(3) Schedule 1, item 4, page 3 (lines 10 and 11), omit the item, substitute:
4 Section 23AA
Repeal the section, substitute:
23AA Evaluation, registration and listing of restricted goods
(1) Subject to subsections (2) and (3), restricted goods may be evaluated, registered and listed in accordance with the provisions of this Division as they apply to therapeutic goods.
(2) A certificate of:
(a) registration of restricted goods under section 25; and
(b) listing of restricted goods under section 26;
is a disallowable legislative instrument of the purposes of the Legislative Instruments Act 2003.
(3) A certificate mentioned in subsection (2) does not take effect before the expiration of the time within which a House of Parliament may disallow the certificate.
I will be speaking on behalf of Senator Scullion so that we can ensure we get through this and that those who want to have the opportunity to speak on this particular amendment will get the opportunity to do so. Although, as many have said during their contributions, this could strictly be seen as a debate on the process of approval of RU486, it is completely inevitable that other emotions, other elements and other sensitivities will be brought into the debate. It is from that perspective that Senator Scullion and I have developed our amendment.
We do not agree that this is just another drug. There is no doubt in my mind that this is more than just another drug that should be before the Therapeutic Goods Administration through the usual process. We believe though that it should proceed to the Therapeutic Goods Administration unfettered. If a company wants to make application to register RU486 or a similar drug for a similar purpose, it should have the opportunity to do so and the Therapeutic Goods Administration, which is rightly recognised as a very competent authority operating on behalf of the Australian government and the Australian people, should have the opportunity to make an assessment of the drug.
We also believe that the Australian community see that as elected representatives we should have some oversight of that process. It is unfortunate that some submissions have called into question the work and processes undertaken by the Therapeutic Goods Administration. Senator Scullion and I believe that there should be some parliamentary oversight of the process in cases such as this, recognising that RU486 is not just another drug. That is the premise of the amendment that we put forward. Any application that goes to the Therapeutic Goods Administration for a drug of this nature should be assessed through the usual process but approval of such a drug should then come back to the parliament as a disallowable instrument so that the parliament, the representatives of the people, have the opportunity for oversight of that process.
I know that in that occurrence other things will be brought into the debate, just as there have been at this time. It could be said that we are now having the debate that should be had, but in my view it needs to go further. Certainly that view is shared by Senator Scullion. A lot of excellent work has been done as part of the process of going through the Senate committee inquiry into this drug. There are a whole range of perspectives. I do not necessarily come to this with a pro-life perspective. In fact, I have had long discussions with my wife about this. In essence, I think I come to this from a pro-choice perspective. But Senator Scullion and I believe that, as this is not just another drug, the parliament should have some oversight of the process.
Senator Barnett, in his contribution earlier, intimated that there might be some flaw in the amendment that we are considering. I have researched that and I do not believe that to be the case. Senator Barnett is referring to a specific variety of drug. The purpose of our amendment is to take the process away from any one individual. We do not believe that any one individual should have the opportunity to restrict the process going forward. From our perspective, this is a very simple process. An application is made, it goes to the TGA and then, in the event of approval, it is overseen by the parliament. In my view, the reference that Senator Barnett made essentially leaves in place another de facto method for one person to stymie the opportunity for women in Australia to have access to this drug, if it is approved by the TGA. We do not believe that that is appropriate as part of this process. Essentially, this amendment supports the proposed process but leaves the final oversight of the approval of this drug in the place where Senator Scullion and I believe it should be left, and that is in the hands of the elected representatives of the Australian people in the Australian parliament.
I do not support amendment (3) or indeed amendments (1) and (2) put up by Senators Colbeck and Scullion. These amendments are designed to prop up the claims made by opponents of the bill that the current arrangement is justified because of the parliamentary scrutiny that is inherent in the current system. But it was pointed out by me and by many others that, despite what the minister and others were claiming, the parliament had no say. The minister was merely required to advise the parliament that he had given approval to an abortifacient—no debate, no vote, no accountability, no criteria.
These amendments are designed to take away the power from the minister. Indeed, they cut the minister out of the question altogether. But this is still flawed, because it leaves the decision to parliamentarians. There are, again, no grounds or criteria for the decision. There are no other pharmaceuticals subject to this regime. The debate would again be about abortion, not about safety and efficacy. As Senator Troeth has pointed out, this place is not in any position to make a judgment about safety and efficacy in any case. It has been said ad nauseam in this debate that abortion is a state and territory matter already decided many years ago and that it does not need revisiting.
These amendments allow the TGA to evaluate RU486, but, if the TGA approves the availability and allows it to be registered or listed, the certificates of registration and listing are disallowable instruments. That means that before RU486 can be made available, even if it can be determined by the TGA to be safe and effective, the parliament is allowed to override that decision. That means that parliamentarians, as I said, are still making the decision, not the body with the expertise, the TGA.
If the drug is determined by the TGA to be safe then the only reason that someone could have for overriding that decision is opposition to abortion per se. By introducing individual moral beliefs into the decision-making process, the proposers of the amendment are giving their own moral beliefs greater precedence than the safety of the drug and the values and experiences of women and their doctors in making the decision. Members of parliament, like all Australians, are entitled to differing views regarding abortion but they are not entitled to use the power of the state and legislation, I would argue, to impose their own personal moral positions on others or to block access to a drug if it has already been proved to be safe for legal medical procedure.
There is also the question of the great disincentive this would provide for sponsors of this drug. They will spend a great deal of money going through the TGA approval process—or will they, knowing that the parliament may well veto that decision by the TGA? So, again, we are going to see the situation of sponsors not coming forward to make it available in this country. I think there will be debate over and over again in this place and, again, it will be over and over about abortion. Will sponsors of abortifacients retry? In which case it comes back to the parliament. Will there be new applications on the basis of new drugs that are abortifacients that will have to go through this process? How much time will be spent tied up in this debate in this place is anyone’s guess. I am not supporting these amendments. We will also not support the removal of the schedule that is inherent in amendments (1) and (2) to follow.
That the amendment (Senator Colbeck’s and Senator Scullion’s) be agreed to.
I advise senators that, as it is after 4.25 pm, in accordance with the resolution of the Senate we will now proceed to the third reading debate. I will go through the rest of the procedure in the committee stage, and then I understand there will be an agreed period of time for the speakers on each side of this debate. The debate will conclude at 4.45 pm, and I understand that there will be a division then. The question now is that schedule 1, items 1 and 3 stand as printed.
Question agreed to.
Bill agreed to.
Bill reported without amendment; report adopted.