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COMMUNITY AFFAIRS REFERENCES COMMITTEE
07/05/2010
Consumer access to pharmaceutical benefits

CHAIR (Senator Siewert) —Welcome. The committee is commencing its inquiry into consumer access to pharmaceutical benefits. I understand you have been given information on parliamentary privilege and the protection of witnesses and evidence. We have read your submission. I invite you to make an opening statement.

Mr Delaat —Thank you for the opportunity to appear before the committee today on behalf of Australia’s innovative medicines industry to discuss matters that are extremely important to ensuring timely and universal access to medicines through the Pharmaceutical Benefits Scheme. Medicines Australia represents the collective interests of the innovative medicines industry in Australia. Our membership comprises some 50 companies. Medicines Australia members manufacture about 80 per cent of all PBS prescription medicines. Our membership is committed to ensuring the long-term financial sustainability of the PBS in Australia. This has been shown though our commitment to recent systematic reforms of the PBS which are estimated to save government $5.8 billion over 10 years.

I do not intend to repeat the arguments presented in the Medicines Australia submission. However, I want to use this opening statement to draw the committee’s attention to the importance to Australian consumers of affordable and timely access to new medicines. Medicines Australia believes that, for Australia to enjoy economic prosperity, one of the key ingredients is a healthy workforce. This is best achieved through a universal health system that provides timely and universal access to medicines. The PBS undoubtedly provides for a significant economic benefit to Australia through significant health benefits achieved. However, the government has a number of policy levers that permit ad hoc interventions into the highly efficient pharmaceutical market. Medicines Australia believes that the integrity of the PBS may be undermined because of several critical policy measures which pose a serious risk to patient access to pharmaceutical benefits.

The first policy lever I would like to discuss is the therapeutic group premium policy. I would like to begin by defining exactly what a therapeutic group is and, more importantly, what a therapeutic group is not. A therapeutic group is defined by the government as a group of two or more different medicines that deliver the same health outcome at the same price. However, for medicines to be included in a therapeutic group, they must be interchangeable with each other at an individual patient basis. As I will discuss shortly, this concept of interchangeability has not been defined.

Finally, a therapeutic group can mean an increased patient cost where the therapeutic group premium is applied on top of the normal patient co-payments. A therapeutic group is not comprised of medicines which are bioequivalents with each other or copy medicines. Such copy medicines are often called generics. Unlike these, the different medicines within a therapeutic group are not able to be substituted for other medicines in the group by pharmacists. A therapeutic group includes two or more different medicines of which there may be many brands. Essentially, the different brands of the same medicines are substitutable and therefore can be substituted by a pharmacist at the pharmacy counter. But, where different medicines are deemed interchangeable, the doctor has to prescribe a different medicine; the pharmacist cannot do that.

We believe that the four therapeutic groups announced last year—the high-potency statin group, oral bisphosphonates for the treatment of osteoporosis, oral bisphosphonates for the treatment of Paget’s disease and a selected antidepressant group—were implemented purely as a PBS savings measure without transparency or due process. The government neither consulted with affected companies or other relevant stakeholders prior to the announcement nor published a summary of their decisions. In fact, PBAC advice to government on the creation of therapeutic groups and assigning medicines to these groups does not appear in the public PBAC document summaries.

There has never been clear guidance given to companies as to the criteria and evidence required to determine whether medicines in a therapeutic group are interchangeable on an individual patient basis. When you get down to it, the concept of interchangeability is ill defined, and this has a variety of implications. The evidence required for determining interchangeability and therefore eligibility for this policy matter is different from that routinely provided within an application for reimbursement. Typically, such evidence is not available from companies’ submissions to the PBAC. So where is the evidence in support of these decisions coming from?

On a number of occasions Medicines Australia has approached the Department of Health and Ageing and the PBAC to seek answers to the questions: what constitutes interchangeability on an individual patient basis and what evidence is used to determine interchangeability on an individual patient basis? No answers have been provided. This lack of clarity creates uncertainty and risk for consumers and affected companies. The risk for consumers is whether these medicines truly are interchangeable on an individual patient basis, whereby patients are able to switch from one medicine to another medicine in that group without detriment to their health. Because the establishment of therapeutic groups may introduce a financial consideration to a doctor’s prescribing—because the physician may prescribe one medicine over another to avoid an additional patient cost—it is critical that conclusions of interchangeability are based on robust evidence.

The risk for affected companies is directly related to business certainty and is created by unpredictable short-term cost savings measures such as therapeutic groups. Companies need a stable PBS policy environment in order to provide timely access to new medicines. The more uncertainty a company encounters in the PBS policy environment, the less likely the company will invest in listing new medicines on the PBS. At best, this uncertainty will delay access to new medicines. At worst, some medicines may not be made available at all. Business certainty is critical to the investment environment. Concerns around reduced access to medicines—those currently on the PBS as well as innovative medicines not yet listed—were raised when the previous therapeutic groups were introduced in 1998.

Another key issue that goes directly to timely access to medicines relates to the current requirement for cabinet approval for certain medicines. Medicines Australia believes that the requirement for cabinet approval of new medicines that cost more than $10 million per annum delays timely access to new PBS medicines. The requirement for cabinet approval was introduced in 2001 and implemented to reduce financial risk to the Australian government. However, the requirement for cabinet approval can delay the listing of these medicines for 12 months or more. While patients wait for the cabinet to review a positive recommendation that has already been made by the PBAC, there is no subsidised consumer access to that new medicine.

As a direct result of this policy, patients may experience deterioration in their condition before gaining access to their medicine and even premature death. New medicines undergo a rigorous cost-effectiveness assessment by the PBAC. Only if the PBAC is satisfied that a new medicine will provide value for money will the medicine be listed on the PBS. In addition, the government has implemented a number of measures aimed at further reducing the financial risk. Measures such as risk-share agreements spread the financial risk between the government and the affected company. We believe it is not good administrative practice for cabinet to be required to approve medicines for listing on the PBS, and we certainly believe that the $10 million threshold introduced at the turn of the century should be increased as recommended by the government’s own Productivity Commission. It makes no sense that patients are being made to wait for sometimes life-saving treatments for a bureaucratic process whose rationale is unclear at best when those medicines have already been rigorously evaluated. At the very least, there are some medicines that simply should not get trapped in the cabinet process, and we are asking for the threshold to be updated to take account of that.

In concluding, Medicines Australia agrees with government that a financially sustainable PBS is essential for sustaining universal access to medicines. However, Medicines Australia believes there are a number of policy levers that risk timely consumer access to medicines and urges the government to, firstly, abolish the therapeutic group policy and legislative provisions relating to it, because it places consumer health at risk and creates business uncertainty; ensure the term interchangeability on a patient basis is clearly defined and guidance provided on the evidence required to establish such a link between these medicines; and, finally, review the $10 million cabinet threshold and process to avoid delays in consumer access to new, innovative medicines.

CHAIR —Thank you very much.

Senator FIERRAVANTI-WELLS —I start on the undermining of the recent PBS reforms. That is very clear from your submission. Is this going to derail those PBS reforms? Is it that bad?

Mr Delaat —Firstly, let me just say that Medicines Australia worked very closely with the government to develop those PBS reforms a couple of years ago and is involved with the implementation of those reforms. What this does is undermine those reforms, because the way the PBS was set up it created two separate formularies: F1 formulary, which is a formulary for single sourced, normally patented medicines; and an F2 formulary for multisourced, normally off-patent medicines—two different formularies. The idea with that was that there would be certainty in the F1 formulary for so-called patented medicines going forward for companies when they bring products onto the market in Australia, whereas in the F2 formulary there would be market competition based on the supply from many, many suppliers of those generic medicines. So the concept of paying for outcomes was destroyed in some way. In F1 the government is certainly paying for outcomes, but in the F2, multisourced formulary the government is really paying the lowest market price based on the competition in that area. They are not paying for outcomes. To reduce cholesterol by a certain degree will cost differently depending on the reimbursed price in that medicine. Essentially, to answer your question, what this does is undermine. By linking products in F1 and F2, you totally undermine the principles of PBS reform.

Senator FIERRAVANTI-WELLS —To pick up the point that you made about business uncertainty, what is very clear in your submission and the submissions of others is that this is going to create such a high degree of uncertainty in future availability, particularly with new pharmaceutical launches in the future.

Mr Delaat —That is right. If companies do not know upfront—if the minister has the power to introduce therapeutic groups on a whim, so to speak, or at least to introduce them without any notice—it makes it very difficult from the perspective of predictability for the company bringing those medicines to the market. They want to know that they will not be hit with linkage to an F2 product, if they are bringing the product into F1, and therefore have that product brought down in price by 12½ per cent measures or other measures which affect those products in the multisourced category.

Senator FIERRAVANTI-WELLS —Even though the PBS reforms were negotiated with the previous government, the opposition at the time and the now minister made favourable comments about the reforms. From your perspective, you have gone into those reforms in good faith and now all of a sudden you have got the minister intervening in the market in a very determined manner. My question to you is: ultimately, this is really about saving money rather than patient outcomes, isn’t it?

Mr Delaat —It is.

Senator FIERRAVANTI-WELLS —That is really what it is about when you boil it down.

Mr Delaat —It is. This particular measure really provides minor savings compared to the huge savings that were going to accrue from PBS reform and will accrue from PBS reform. PBS reform was originally estimated to save the government $3 billion over 10 years. It is now been estimated to be almost double that, with $5.86 billion savings over the 10-year period. So this measure is very small in comparison to what would happen with the efficient implementation of PBS reforms. They are going to deliver the big savings.

Senator MOORE —When you say ‘this measure’, you mean the therapeutic—

Mr Delaat —The therapeutic group premium measure, yes.

Senator FIERRAVANTI-WELLS —In effect, for a cash-strapped government, it is a convenient way to find money. That is really what it boils down to, Mr Delaat.

Mr Delaat —That would be our view of why this measure has been introduced.

Senator FIERRAVANTI-WELLS —That is right. So it is about picking and choosing drugs that are going to deliver a big bang for your buck and get good savings, and that is some money, despite what protestations or assurances may have been given in the past about supporting the PBS. That is what it comes down to politically, doesn’t it?

Mr Delaat —Certainly, that would be view.

Senator FIERRAVANTI-WELLS —Can I take you to the definition of interchangeability, which is a topic in your submission. In both your submission and your opening statement you mentioned that you have asked the department about the issue of interchangeability. What specific information or documents have you sought from the government in relation to a definition of ‘interchangeability’?

Mr Delaat —I might ask Mr Bruce to answer that one.

Mr Bruce —On a number of occasions we have spoken to officials from the department and even the PBAC. The term ‘interchangeability’ on a patient basis appears in the National Health Act, so in our minds it is a term in law. It is an issue that causes substantial uncertainty for companies, so we thought it reasonable that they provide some sort of advice as to what it in fact means and what the evidential requirements for that are. It was never a question of disputing the legislation at this point in time; it was simply: can you provide our companies with some guidance?

It is one area where we have found our relationship with the department and even with the PBAC a little bit strained. They have quite obviously been reluctant to talk about this at all, which I guess brings it back to this idea that we suspect it is principally a pricing issue masquerading as a clinical issue, because at the heart of it, if it was a clinical issue, I cannot see why they would be so reluctant to sit down with us and say: ‘This is what we think this means. These are the sorts of things we’re looking for. These are the sorts of characteristics of products that we think we would comfortably group together, and this is the evidential basis of those decisions.’ As I said, we just have not had any success whatsoever with that. We have asked them on a number of occasions, formally and informally, and we have basically been stonewalled on it.

Senator FIERRAVANTI-WELLS —Mr Bruce, I have two questions on the legalities. I would appreciate your assistance in relation to this. In the National Health Act, section 84AG says, about the minister making a determination in relation to therapeutic groups:

… the Minister must obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee in relation to the proposed determination.

But, interestingly enough, in making that determination, it says:

… the Minister may have regard to advice … by the Pharmaceutical Benefits Advisory Committee to the effect that a drug or medicinal preparation should, or should not, be treated as interchangeable on an individual patient basis with another drug or medicinal preparation.

It raises the question: who initiates the determination? Is it the minister or the PBAC?

Mr Bruce —It is difficult to tell. The groups have been formed around the MYEFO and the budget consideration. So, even more than usual, I guess, it has been more difficult to understand—

Senator FIERRAVANTI-WELLS —That lends credence to it being a budget issue rather than a health issue.

Dr Shaw —I think that transparency around the process is not there, so we actually do not know the process of how those groups are formed or how they are initiated. The first we find out about those particular groups is when they are announced either in the budget or in the MYEFO. There is no consultation prior to that.

Mr Bruce —I think it is also interesting that there is another section of the act under which the PBAC is obligated to provide to the minister, at a point of listing a drug, whether that drug is to be considered interchangeable on a patient basis. For all other decisions, the decisions of the PBAC appear in the public summary documents a couple of months after those decisions, as a point of transparency. There is, for some unknown reason, a reluctance to include this part of the advice to the minister in those decisions.

CHAIR —Can I seek clarification. When the initial decision is made, there is a decision made about interchangeability—is that what you have just said?

Mr Bruce —When there are applications for a new listing to the PBAC, the legislation, as far as we understand it, obligates the PBAC to advise the minister if they believe that it is interchangeable on a patient basis.

CHAIR —And that is the bit that is not in the public notification?

Mr Bruce —There is nothing about that in the public summary documents. I get to see documents that companies do not get to see—committee-in-confidence documents that I cannot pass on—so I know that somewhere in that advice it has been provided. But I cannot for the life of me see what is so special about this advice that it cannot also be made transparent to the company at that point of decision. It is curious, at best.

Senator FIERRAVANTI-WELLS —Following on from Senator Siewert, the problem is that there is no definition in the legislation or the regulations relating to the National Health Act that defines interchangeable on an individual patient basis with another drug or medicinal preparation.

Mr Bruce —I would go even further than that. It is actually downright confusing, to the extent that the word ‘interchangeable’ appears in the National Health Act on a number of occasions meaning different things depending on the context, so to be able to infer the definition from one to the other is confusing at best.

Senator FIERRAVANTI-WELLS —What do you see as the appropriate definition of ‘interchangeable’? It is obviously a problem legislatively. How would you fix it?

Mr Delaat —I do not know that there is a very simple, pat answer to that question that we could provide here, other than to say—

Senator FIERRAVANTI-WELLS —Please take it on notice, Mr Delaat. It is clear that the definitional issue about interchangeability is going to exercise us today. If Medicines Australia has a view as to what the appropriate definition should be or where you believe there should be reform of these areas, then certainly I would appreciate receiving that.

Mr Bruce —We have done some work on this and I think we would be happy to provide the committee with some of that work. As a principle, if a patient has been taking a certain drug for a period of time and they have stabilised on that drug and are getting good outcomes on that drug, there has to be confidence that that patient can be switched to another medicine without detriment to that patient’s health. There are some technical evidentiary requirements that would need to be satisfied to have that confidence, and I think we have done some work on that. We did not bring it today, unfortunately, but I think we will be glad to table it at a later date.

Senator FIERRAVANTI-WELLS —Given the time restrictions, I would just like to ask you how you would see improvements being made to increase transparency. You make comments in your submission in relation to that. You may prefer to answer it now or to take it on notice and provide further evidence to this committee.

Dr Shaw —We are happy to provide evidence on notice. A general comment would be that at the moment the groups are announced essentially in the budget papers with no consultation with the companies or notification. The first the companies or the industry find out about it is on budget night or in the MYEFO documents. Some sort of process at least where the companies are involved in the discussion prior to that would be a step forward. We will certainly provide some more comments to the committee.

Mr Bruce —The thing it needs to get back to is that we believe this undermines the very principles upon which PBS reform was founded—that is, there are two different price-setting mechanisms: one is F1, which is what the evidence suggests is value for money, and the other is F2, which is a commodity market where competition drives prices lower and the government gets efficiencies and savings out of that. We do not believe that this policy per se should exist. It undermines the agreement that we have come to.

Senator MOORE —I want to clarify a couple of points. Your concern in this process is the four groups that were introduced last year; you have no concerns with the previous groups—is that right?

Mr Delaat —We have concern with therapeutic group premium policy overall. It originated over 10 years ago. We would like to see it removed from legislation. We think it is bad policy. For all the reasons that we have elaborated on today and in our submission we believe—in the context of the PBS reform; prior to PBS reform a couple of years ago it might have had a place—that certainly today, with an F1 and an F2 formulary, different formularies with different objectives, it really does not have a place and therefore is bad policy in today’s environment.

Senator MOORE —Did the discussion of interchangeability refer to the original groups as well, or has that only become important since last year?

Mr Delaat —The issue has been important for 10 years. For the PBAC, as I am sure Professor Lloyd Sansom will say later on today, interchangeability is based on whether a product is submitted to the PBAC on a cost minimisation basis as opposed to a cost-effectiveness basis—in other words, it is not inferior to the product with which it is being compared. But that is really saying the drug is not inferior on a population basis, not when you get down to individual patients taking individual medicines and then being encouraged to change because they might have a premium put on top of them. There is a difference between a population basis submission to the PBAC and interchangeability on a patient basis.

Senator MOORE —I still want to clarify. We have been struggling with this as a committee over many years. You know; you have come before our committee a number of times. With regard to the issue around interchangeability: was that only introduced last year?

Mr Delaat —No. Therapeutic group premium policy assumes interchangeability. If you go back to 1998, with the first groups, it would assume that those medicines could be interchanged.

Senator MOORE —So the concept of interchangeability has been around since the beginning of the therapeutic groups?

Mr Delaat —Yes.

Senator MOORE —Mr Bruce has been talking about the inability to get a definition. Has there been an inability to get a definition for over 10 years?

Dr Shaw —I think it is the first time in a piece of legislation, as far as I am aware.

Senator MOORE —I understand, but this is a longstanding issue. It needs to be considered, absolutely, but the focus on the last 12 months interests me as well. We need to get to the bottom of it. The department’s submission to us refers to a discussion we had in community affairs with the then assistant secretary of the department and includes a paragraph on interchangeability, which seems to be the basis on which publicly people have concerns. Your view is that the wording does not meet the requirement of interchangeability for your industry; is that the core point?

Mr Delaat —Yes.

Senator MOORE —Okay. But this has been longstanding—

Mr Delaat —Yes.

Senator MOORE —and in fact therapeutic groups as a whole policy, not specifically what happened last year, is part of an ongoing debate?

Mr Delaat —Yes.

Senator MOORE —I want to clarify something that is really important in terms of the ongoing discussion with the department. Your submission and evidence indicate that you have been trying to get some response. I am interested to know exactly: do they not respond? The way your submission reads, you ask them; you want a definition. Would the response be, ‘We’re not giving you one’? Would it be, ‘We’re moving on to another paragraph and ignoring it’? From your perspective, what is the response?

Dr Shaw —The response is fairly circular, I think, because it is: ‘What’s interchangeability? Well, it’s something that’s interchangeable at a patient level.’

Senator MOORE —Sure.

Dr Shaw —Then we ask them, ‘What does that mean?’

Senator MOORE —‘So what is world peace?’—that kind of thing?

Dr Shaw —Yes.

Senator MOORE —So the word is used without definition?

Dr Shaw —That is right. Eventually the discussion becomes: ‘Well, it’s when the PBAC recommends that something is interchangeable at the patient level.’ We say, ‘Okay, what does that mean?’ They say, ‘When the PBAC says it is.’ I think it is probably fair to say that it has been a circular argument. There is no list of criteria, no definitions or anything like that.

Mr Bruce —The closest we got to any specific advice was that cost minimisation—that is, a product is cost minimised to another—is a necessary but insufficient condition. On that basis—

Senator MOORE —I think I would need to see that written down.

Dr Shaw —There are lots of drugs that can be cost minimised together that you would not call interchangeable—drugs for mental illness and depression, that sort of thing—so it does not provide the clarity that is needed.

Senator MOORE —We will certainly ask other witnesses about this. The concept is that they are a group of drugs that serve a similar purpose—and I will not get into debating a definition. There is always the ability, and always has been the ability, for the practitioner to determine which medication someone uses. This legislation does not change that at all, so the concept that this is overriding the role of the practitioner in discussion with the client is not affected. What you are saying is there could be other things that colour that.

Mr Delaat —It brings in a financial consideration for the doctor which would not have been there otherwise. In other words, now the doctor has to consider whether the patient, who may only be paying $5.30 as a pensioner for a prescription, may have to pay an extra $3 or $4 in additional premium, which would take the cost up to $8 or $9 when they are taking four or five other medicines as well. So there is a financial consideration: ‘Is this the right medicine of this patient? It may be, but I don’t really want to give that financial burden to the patient because they can’t afford it.’

Senator MOORE —As opposed to the ongoing discussion about whether it is on the PBS or not, which has always been part of the process, and also the discussion we have had in this group about whether a generic drug will serve us. We have had a long discussion about that, which has already been part of the process for many years. You are saying this is an added impost.

Mr Delaat —It is.

Senator RYAN —I have a couple of brief questions because this is an incredibly complex area. In terms of therapeutic groups, the submission is based on population data, the effect of medicines across populations. I just want to make clear that they are not actually the same molecules that are being grouped together, they are actually different medicines—different forms of statin and different forms of antidepressants.

Dr Shaw —Correct.

Senator RYAN —It is fair to say that even though they may be equivalent of a population level any one of those statins or an antidepressants may work in someone better than it works in someone else, so patients may need to change.

Dr Shaw —Correct.

Mr Delaat —And particularly in mental health, because antidepressants and other medicines used in mental health are so idiosyncratic in the way that patients respond to them. As the Epilepsy Foundation’s submission said, they have case studies where even when a person goes to a generic version of the same medicine they get out of control, let alone going from one medicine to a totally different medicine.

Senator RYAN —I want to explore that in relation to antidepressants and the therapeutic groups there. When you are treating people or trialling them on different medicines, there is a period of titrating doses are up and down in between changing medicines, isn’t there?

Mr Delaat —Correct.

Senator RYAN —So the idea that some of these medicines might be interchangeable at a patient level for that class of medicines is basically ridiculous because you would be titrating people down on a dose of one before you could put them on another one, and that is assuming they could be stable on both.

Mr Delaat —That is correct. If you take the statins, where there are four or five different dose levels for cholesterol lowering and side-effect profiles, patients might get some unwanted effects at high doses so you titrate backwards. So there is always that titration period, and then to think that you can switch them easily to another product means you have got to go through the whole process again.

Senator RYAN —I think that is one of the more important points. There is often an assumption that the question of therapeutic groups can be mixed in with the debate about generic substitution.

I want to go to the issue of cabinet approval of medicines, which I know has been covered on numerous occasions. Your submission talks about what is effectively a 50 per cent increase in the delay of approval of medicines at cabinet, from 200 days to just under 300 days—a full year. Have you been given any explanation of why there has been a 50 per cent increase in two years in the approval of new medicines?

Dr Shaw —No, we have not. My understanding is that it is based on just an observation of the date when the PBAC makes a positive recommendation to the date that it is listed on the PBS, and that is just an analysis based on publicly available data. Our view is that the cabinet process generally adds six to 12 months to listing time. Given that Australians are already waiting three years for a medicine to appear on the PBS, that process needs to be looked at. All we are saying in the submission today is that the threshold where that cabinet approval needs to kick in needs to be readjusted, given that the level was set back in the turn of the century.

Senator FIERRAVANTI-WELLS —In fact, you are correct. In answers to questions at estimates the government has admitted that it has doubled. It has gone from about 5.5 months to 10 months, so you are absolutely correct. Before the last federal election, Medicines Australia, I think, was given some commitment by then shadow and now Minister Roxon in relation to the threshold. Did you get that in writing?

Dr Shaw —We can investigate that. We are happy to take that on notice.

Senator FIERRAVANTI-WELLS —In other words, she gave a commitment that she would look at the threshold.

Dr Shaw —As I understand it, yes. We can have a look at that.

Senator FIERRAVANTI-WELLS —What has happened in relation to that?

Dr Shaw —We have subsequently approached the government in discussions about increasing the cabinet threshold, and I think the response has been ‘it’s a cabinet matter’. As I say, our argument has always been that the threshold should be increased. The $10 million threshold was set back in 2000 or 2001, and even just by indexing it to inflation it would be up to $20 million. We think it needs to be increased.

Senator FIERRAVANTI-WELLS —Dr Shaw, can you take that on notice and see if you can produce that letter. It might turn out to be a bit like the letter that the Prime Minister wrote to Dr Armitage about private health insurance: it may not even be worth the paper it is written on. But if you could give that to the committee that would be very helpful. Thank you, Doctor.

CHAIR —We will take that last issue as a comment.

Senator FIERRAVANTI-WELLS —I am entitled to comment.

CHAIR —Unfortunately, we are out of time. Thank you very much. We have given you quite a bit of homework, I think!

Mr Delaat —Before we go, if I could just make one point. I notice that one of the later speakers before the committee is Professor Lloyd Sansom, Chairman of the PBAC, and he has not provided a submission to this committee. We would respectfully request that there be some opportunity for us to respond to what he has to say, because we have not seen what he is going to say. He has not put in a submission and we would like the opportunity to respond.

Senator FIERRAVANTI-WELLS —Yes.

CHAIR —There is always an opportunity for people to put in supplementary submissions, and of course we accept supplementary submissions. Just bear in mind the time frame.

Senator FIERRAVANTI-WELLS —Chair, on that point, we may need to recall some witnesses based on what evidence the department presents. That option should perhaps be considered at this point.

CHAIR —That will be a decision for the committee. But, yes, it is our practice to accept supplementary submissions.

Senator MOORE —As you know, Mr Delaat!

Mr Delaat —Yes.

CHAIR —Thank you very much. We do have a fairly tight time frame on this inquiry; so, if you could get your homework done—

Mr Delaat —Certainly.

CHAIR —so that it facilitates our review of that information, that would be appreciated. Thank you.

Mr Delaat —Thank you very much indeed for hearing us.

[9.07 am]