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

Obviously, the therapeutic goods amendments that are being discussed today in this debate on the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 touch on some very important ideas. Though it is not immediately obvious when you read the legislation, it is actually making some significant changes. The TGA of course plays a very important role in monitoring therapeutic goods and devices, and poisons as well, on behalf of the secretary of the department. Much of the debate on and consideration of this legislation has been about the responsibility of the Commonwealth, to be playing a role in the control of poisons—as they do for therapeutic devices and, of course, medicines themselves.

Another key issue that comes up every time we talk about TGA related issues is the role of complementary medicines. It was good to see the CHC and the Australian self-medicating industries having some say as well in these changes. But in the end we come back to the Australian Constitution—to subsection (60 (i) and the fact that it really does not clearly spell out the role of the Commonwealth. Those who have worked in this area—and I can go back to 2001 as an adviser to the then health minister—would know that we have worked very hard to get synchronisation between the states, to make sure that we do not have too much expectation on the TGA to operate on its own. It has to do so with other offices: the offices of, I think, chemicals and environmental health in the Department of Health and Ageing, all of which come together—as I note Charles Maskell-Knight has noted in his submission—under the secretary. Why do they do that? Obviously, you cannot afford to have every single decision about regulation coming back to this parliament. At some point that has to be devolved to the secretary, which it is—and remember that the TGA operates as a division within that department.

But I do recall the RU486 debate, which obviously galvanised both the country and this chamber back in 2005. The debate there, of course, was on a highly controversial therapeutic agent. Where the TGA alone is responsible for safety, clinical efficacy and quality, can they actually be expected to be making moral and ethical decisions around pharmaceuticals? It is relevant to this legislation that one of the amendments that I put up, with the support of a coalition senator, was that, for truly controversial pharmaceuticals, there probably should be some kind of recourse beyond the secretary and the TGA back to this parliament. Of course, that amendment was defeated, and the prime reason for that was that you cannot imagine that every single therapy could potentially be referred back to this chamber, and I have some sympathy for that. But I am also mindful that, in the two or three decades where we have had these issues, RU486—which has been around for a number of decades—has been the only pharmaceutical of which it has ever been contemplated that it should come here for debate.

So we are hardly going to be overwhelmed with requests. But I think it would be an important avenue, because we are all aware what is just around the corner in therapeutics: genetically modified organisms and pharmaceuticals that will be testing the boundaries. At the risk of describing a therapy that does not actually exist at the moment, there may be a day where there is a pharmaceutical that one could take, as a mum, to abort, selectively, a male or female foetus. We would be completely unable to deal with that through the TGA under the current arrangements, and there may be, one day, a rush to look at these regulations and provisions again when something highly controversial comes along, where I think ordinary Australians would like to have a say about what is on the pharmaceutical shelves around this country or, for that matter, what is sold in health shops.

That aside, what we are doing today is extending the powers, somewhat—first of all by separating medicines and poisons, and that has always been a little bit of an issue. We can go back to 2001, when the Australian Health Ministers Conference turned their minds to it and commissioned the Galbally review of 2001, which was responded to by an advisory committee’s working group in 2003. There was some hope that we could one day move to an Australia-New Zealand arrangement for therapeutic products, through a transnational authority. It was the great vision of the early 2000s. It was disappointing that, around July 2007, that was delayed. Subsequent groups have worked to still bring forward some of those fairly sensible regulations in an Australia-only context.

So what do we have? We have a separation of medicines and poisons—and I am aware that you do not want them to be too separate but you do want them close enough so that we have effectively the one, overarching, structure, so that there can be transmission and dissemination of information between those two bodies. But you still do not want to join them completely so as to have both medicines and poisons being regulated by the same body. There is a sense that that would be a little cumbersome under the constitutional arrangements that exist at the moment—those arrangements where the states still do take the lead, in the main, for the regulation of poisons. I think they turn to the Commonwealth, in this slightly vexed federal arrangement, for the overall guidelines, but then we hope that, through identical structures in states and territories, they can make their own decisions—and that seems to be where we fall so often on federal issues like this.

Secondly, we are enabling the secretary also to determine purposes for which medical devices cannot be used on the Australian Register of Therapeutic Goods. That makes sense. You can imagine that there is a wacky little device that can be used by, say, a medical specialist, and they talk amongst themselves at conferences and say: ‘Do you know what? You can also use this device for something else.’ All of a sudden you have moved beyond the good work of the TGA, because this device is being used in some other context. So, instead of boring out one hole in the human body, it is being used to bore something else. Clinicians may well have some information, some evidence from overseas, but it has not been submitted to the TGA and has not been scrutinised. I think that it is only fair that we should be pushing for that to occur. One way to do that is to enable the secretary to make some decisions about how devices cannot be used.

I just state one caution there. There are some very common-sense ways in which devices can be used. Some rarely-used devices—often very expensive devices or devices for which there is an enormous cost for the manufacturer to go through the approval processes in a range of the developed economies where they are available—could be looked at using common sense. There is a countervailing view that clinicians in the end are responding to cutting-edge science. It may well not be the sponsor who has the energy to bring it forward to the TGA and the TGA’s hands are tied, in a sense, in that respect. If it has not been brought to them, the TGA can hardly be expected to go out and do the research on very specific uses of these products. So I can see that there is a balance. I would like to know that there is still an opportunity for unusual medications and unusual devices to be used within the current expectation of clinical experts in their field. We can only hope that either sponsors or manufacturers make the effort to apply for approval and have it granted in this country.

Finally, we are looking at increasing the provisions for consultation with the Gene Technology Regulator. The area of genetically modified organisms—that is, products that either are genetically modified or contain genetic modifications—is very controversial. It is an emerging area. One thing we know is that the field is moving faster than politics, which is moving faster than community understanding, and whenever that happens there are tensions and uncertainty. There has been a great deal of unease within the community about the use of GMO. so all I can recommend is that the government spends more of its time and resources making sure that people fully understand and are brought up to date with the implications and the potential for GMO—without the scare campaign that often goes with it.

The last area, which is just a tiny change, is obviously increasing the offences for not just sponsors but also anyone who advertises a therapeutic good. I do recall some of the situations where the supply chain, particularly around complementary medicines, has been brought into question. Whilst still having great integrity in this country, many of these products are deemed to be less dangerous, and I commend the TGA for still having at the moment a fairly balanced view. You can have a scheduled pharmaceutical or you can have one that is more freely available, and then you can have complementary therapies. Most of them are amino acids and natural ingredients, and there comes a point where overregulation just becomes completely ridiculous. We do have to strike that balance—and I can see the nods from the other side of the chamber. There is just no point setting the TGA loose on certain natural therapies that have well-known and well-tried natural ingredients. Again, there has to be a balance. Where they are combined or in unusual strengths, where they report certain adverse reactions or where they are used for indications that are not conventional, I can understand the requirement of sponsors and people who import them to hold the evidence. I think it is very important that that information is available.

I will give you an example. A well-meaning lady in her 70s is diagnosed with dry macular degeneration and she obviously turns both to conventional and complementary medicine for anything that will preserve her sight. There is no surgical option and at the moment there is no pharmaceutical option for the treatment of dry macular degeneration. But there are plenty of complementary medicines out there, which must be incredibly luring to someone desperate to save every bit of vision that they can in a disease that has a fairly relentless progression. So she goes and purchases these products. She purchases them in a fairly unregulated environment and there is potentially a very serious adverse reaction, which in the end can be tied back to that therapy. What role does the TGA have there? I would like to believe that anything that is on the shelf can make a health claim only if it is backed up by evidence. That is fair enough, and that is how it is at the moment.

In this legislation I support further efforts to increase some of those offence provisions, and not just against the sponsor, if that were to occur. Let me explain why. We need to be able to turn to those importers and know that those pharmaceuticals have been manufactured in the highest quality manufacturing facilities, just as we would apply to local producers. You can see that if you are manufacturing locally with standards that are far higher than you accept from your imports, you are already setting up an unlevel playing field.

There is an even greater concern for me, which is that, when you try to block these products, what can you do? You can take action against the sponsor or the importer, but is that enough, because another sponsor can potentially appear. At the same time, this sponsor has actually disseminated the product around the country and it is sitting on shelves. Small business people have expended inventory, time, space and resources on stocking this product but of course no action can be taken. So we have this sort of invidious position where the TGA can potentially target a sponsor for errors in advertising or for making claims that cannot be backed up by evidence, but we still have the retailers who have made significant investments. In the past, many of them were unable to remove those products from the shelves if those advertising provisions did not apply to anyone, not just the sponsor.

In summary, this is important legislation. It has a history going back at least 10 years for the great vision that we had for Australia and New Zealand working together. It does not seem extraordinary that, for 26 million people, we could not find a way of working together for a trans-Tasman agreement. Let me remind members that the implication of parting from New Zealand is not insignificant; there are significant import situations where New Zealand authorised products appear on shelves here and are effectively able to bypass our TGA arrangements—one area is stimulant sports drinks. I know that mums and dads around the country have valid concerns about stimulants being added to sports drinks, and that is one tiny area in which we cannot afford New Zealand to be the back door to Australian supermarket shelves. That is an area we have tried and have fallen back somewhat, so this legislation, important to mention today, starts to make sure that those regulations become realistic, even though we fell away from that trans-Tasman agreement of a therapeutic products authority.

It is good that these additional powers fall to the secretary of the Department of Health and Ageing; it is excellent that these provisions for advertising are being strengthened; and, last of all, it is important that therapeutic devices cannot be used too far beyond the area for which they have already made their application to the TGA. It will keep some balance between common sense and, of course, the risk that clinicians will tear off on their own and use devices, in those rare opportunities, for other clinical causes for which evidence is not available. For all those reasons, it is really important that both sides support this bill.

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