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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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