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Wednesday, 14 May 2003
Page: 14369


Mr BILLSON (11:49 AM) —I cannot confess to being as animated or as colourful as the previous speaker on the Therapeutic Goods Amendment Bill (No. 2) 2002 but I hope to put some thoughts on the table today that may assist in dealing with what is a matter of serious concern not only to many people in the community, many retailers and small businesses in my electorate but to this parliament. What we are discussing today is a big deal. Some seek to portray the alternative and complementary medicine industry as a cottage industry, something akin to home brew. It is not that; it is a $1.2 billion manufacturing outfit. That is manufacturing alone, not taking into account mark-ups and retail activities.

According to research, in the next 12 months more than half of all Australian citizens will reach for an alternative or complementary medicine. I am one. I take Echinacea and odourless garlic tablets in the hope that I do not get the dreaded Canberra lurgy coming up here. Do I know whether it helps or not? I am not certain, but I have been advised that for others it has worked, so I thought I would give it a go. I am one of those people who are part of that 50 per cent, perhaps in contrast to the previous speaker, and hold some hope that these remedies have some good going for them and that they will help with my wellbeing.

I think that is what we are talking about today—the attractiveness and appeal of complementary and alternative medicines. We are all looking for improved wellbeing, we are all looking to maintain our health and we are all keen not to become pharmacologically dependent to achieve that, so we turn to these often natural complementary and alternative remedies for assistance. We look to science, we look to alternative cultures, we look to long histories and we look to the referrals of our friends to give us an indication of what works and what does not.

I talk about what works and what does not because at times this conversation turns into a dialogue about the efficacy of those products: do they actually do anything? The member for Bonython was quite eloquent in canvassing some of those issues. That is one issue that we need to address, but we also need to make sure that what we are consuming is what it is said to be. That is what these changes that we are discussing today are about. They are about ensuring that there is an audit trail, and that the manufacturers—and those supplying others for rebranding of their products—are doing what they say, and have in place the systems to validate the accuracy and quality of their work. These changes will ensure that manufacturers can provide that evidence to the regulator and their customers. Their customers, in many cases, are wholesalers or retailers of these products in communities right around Australia.

These changes are about ensuring that if something is not quite right we can track it down. It is no good collecting data that does not mean anything. There is no point having records that cannot be found. It is certainly of no assistance to the integrity and credibility of this sector if people accumulate data on what they are doing that bears no resemblance to reality and, when that data needs to be relied upon to bring about a correction of a manufacturing fault, it does not take you anywhere. So we are talking about an audit trail, not just the steps and motions of quality control. We are talking about having that material available so that, where there is a need to remedy a fault or there is some nonperformance by a manufacturer, the Therapeutic Goods Administration have the regulatory tools and the cooperation—at least, not the obstruction—of those they are seeking to regulate.

This is a timely debate. It has been on the Notice Paper for some time and events in recent periods provide evidence of the need for these changes. Pan Pharmaceuticals have done the industry a great disservice. I have spoken to a number of natural remedy providers, health food store owners and naturopaths in my electorate, and they are devastated. They are devastated about being let down. Tamara, at Beleura Natural Therapies in my electorate, feels extraordinarily let down by the suppliers. She was purchasing products to retail in her business and to support her practice. Her business has been up and going for 18 years, supported by her own studies and research. Part of her business involves the retailing of these products and she has been let down by her suppliers.

She has been let down by Pan Pharmaceuticals and by the people who purchase Pan Pharmaceuticals products and rebadge them. What has happened in recent times is extraordinarily frustrating for her because there are some who already question the credibility and efficacy of some of these remedies and products. Consumer confidence was beginning to be built up as more was learnt about these products and this path to wellbeing but consumers have been let down by those profiting from them—the manufacturers.

She is appalled and deeply concerned about the loss of consumer confidence in her industry, which has resulted from the appalling performance of Pan Pharmaceuticals. She was wondering whether there would be an opportunity for the TGA to be more interventionist. We have heard from some speakers on the other side that the TGA has been too heavy handed. We have heard from those in the industry that they have been involved in a witch-hunt. But someone in the industry is saying, `Maybe there's a case for the TGA to be more interventionist and to be absolutely rigorous in checking these issues.' It is an interesting contrast.

That is the beauty of the arguments of those who are critical of the reforms the government is discussing today. You can have it each way. If it suits you, you can say the TGA have been too heavy handed, too interventionist, overly cautious, motivated by the consumer and not sensitive to the needs of the manufacturer. That is one argument. Or you could ask, `Why didn't they act earlier? Why didn't they pick up the fact that a few people were having bad experiences with these products and recklessly go in and rough up Pan Pharmaceuticals?' You cannot have it both ways. What is needed is a balanced approach, and these measures that are before the House today are a part of that.

This issue raises some interesting questions. I read with some interest, and frankly some surprise, a letter by Vaughan Bullivant that has come my way. Vaughan Bullivant, living in Queensland, did quite well. He sold his business—with brands like Nature's Own, Natural Nutrition and Bio-Organics—to Mayne Health. And why wouldn't you? It was a lucrative business which, I understand, went very well. He no longer owns that business; it is Mayne's. In this extraordinary letter he is having a spray at everybody except those charged with ensuring that what they are claiming is in the product is actually in it. He says:

It's easy to knock a tall poppy.

No, Mr Bullivant; that is not what this is about. To use your language about tall poppies, it is about making sure the poppy is a poppy and not a carnation or a Schmackos dog biscuit. That is what this is about; it is not about knocking a tall poppy. If you are going to flog a product with `tall poppy' on the can, there should be tall poppy in it. If you are only going to put a poopteenth of tall poppy in amongst some other constituent parts, the amount you say is in it should be in it. That is what this is about.

This is not some reckless, heavy handed way of fixing up the complementary medicine industry. It is nothing like what is described in this extraordinary letter that claims that the TGA have obviously gone out of their way to destroy a huge company. This is the biggest own goal in alternative medical history. They have kicked it themselves. This was their mistake at Pan Pharmaceuticals. This was their error that the TGA have rightly identified and sought to remedy so as not to place the consumers of Australia at risk. That is what this is about. It is not about, as Mr Bullivant would say, a personal vendetta against Jim Selim. The only thing that is personal about this is the grief that people feel because they have been let down by Pan Pharmaceuticals.

In this letter you can read where he was reminiscing. Why wouldn't he reminisce? Bullivant's natural health products had a great reputation, as I understand it. They had occasional conversations with the regulator but Mr Bullivant talks about how they had 34 individual quality control checks over the time he was involved. Active herbs were identified and nothing was dispatched unless he was absolutely confident that what was on the label was in the product. It sounds as if we are on the same page of the same hymn book.

From what he is saying, he is an advocate for these changes. But his justification seeks to discredit the TGA's performance and the government's measures. It is odd. What he is saying he did is what we would like all people in the industry to do. He is talking about labelling and having the highest quality ingredients with `no artificial rubbish to cut costs, and the potency would be guaranteed to exceed the expiry date'. Great stuff! Bravo, Mr Bullivant! But he then goes on to apply his credo to Pan Pharmaceuticals and says that there has been a personal vendetta against Jim Selim. I do not think it is a personal vendetta against Jim. I know a lot of people in my electorate whose businesses have suffered because of his company's nonperformance feel that it is personal. They feel very let down.

Mr Bullivant goes on to say that freedom of choice for personal health care has always been a passion of his and Jim Selim's. He says that dealing with government regulators is like dealing with ignorance and that there is `a bias against our industry'. It is quite a remarkable outburst—and I can only describe it as an outburst. He talks about how through many years he has fought ignorance, inflexibility, incompetence—all these sorts of things—and claims that being regulated amounts to an injustice. If you are soaking up $1.2 billion from producing and selling something that claims to give certain benefits, it is not unreasonable for consumers who buy that product to get what it is claimed they are being sold.

In this letter Mr Bullivant asks, `Do they care that possibly hundreds of health product retailers could soon become bankrupt?' and he gets stuck into the TGA and the government for that. Mr Bullivant may be retired now, but he has missed the point here. It was not the government that made the product. It was not the TGA that put anywhere between zero and 700 per cent of the amount of active ingredient in products. It was not the government or the consumers that, when Pan Pharmaceuticals were asked to cough up evidence of their quality control and content in their products, could not find such evidence and there was a lost password and then a wiped disk and all sorts of uncomplimentary behaviour by the manufacturer. As Mr Bullivant says, this whole fiasco is a crime—and it is a crime. That is why I hope some people are charged and I hope some people are punished. This has done an enormous disservice to this entire industry and it has damaged consumers and small businesses in my electorate.

Let us talk about the broader issues here just for a moment. Mr Bullivant says that it needs urgent retaliation by health product retailers and the people of Australia—some retaliation for the measures that the government has taken. I am not quite sure whether this is just pure gusto and bluff, but the frustration of consumers and small businesses in my electorate with whom I have spoken as late as an hour ago is not directed at anybody other than the people who let them down, and they were the manufacturers—not all of them, just Pan Pharmaceuticals. This has been made more difficult by not knowing what that company had made or where it had gone; we could not track down what had been rebadged. Doesn't that evidence the need for an improved audit trail on these things? Isn't that screaming support for the bill that is before the parliament today? Why wouldn't we be looking for those things?

I said earlier that, if it is going to be a tall poppy, make sure that it is a poppy and not a stalk or a carnation; make sure of what is actually in it. There is a reason for that. Some of these products are rightly recognised as foods in that there are no claims that consuming them will have any medical effect. There is no medical claim made about them. You might remember that a few years ago you could buy crystals that alleviated rheumatoid arthritis and things like that. No evidence could be provided to support those claims, so the crystals needed to be described as something else minus the claim that they will fix a lumbago problem. In that respect, the test was: sell this stuff, make no claim, but make sure it does no harm. That is the first level: make sure it does no harm. If we are not certain of what is in the product, how can consumers be sure of it not harming them? That is the first level of these products.

The second level of these products is that the history of many of them, particularly those of traditional and Chinese medicine, dates back centuries. Something happens and from their consumption some medical consequence is evidenced. You could look even more closely at things like folate consumption prior to and around the time of conception as being helpful in alleviating spina bifida cases. That is at the second level where we think there is some good, some wellbeing and some health-giving benefits from consuming these products. But again it is important to know what is in such products and for those claims of medical consequence to be validated by research.

As was said by Peta, a pharmacist at the Belvedere Park Pharmacy in my electorate, to whom I spoke this morning, there is a recognition that complementary medicines do in many cases, in many people's lives, sit alongside more pharmacological remedies. So pharmacies, through their accreditation processes and the like, are making sure that their professionals understand more about these products because there is some evidence available that supports their wellness and health-giving outcomes. If those claims are to be made, they need to be backed up and supported by evidence. And what is actually in such a product needs to be what is said to be in it. So those double-blind tests that are part of verifying such claims actually stand up, because your claims are based on a consistent ingestion of these products. So claims must be supported and Peta pointed out some examples of where that was the case. Gingko was one example where there are some rheumatoid benefits, and those claims are made. They are modestly made. They do not say that you will become an athlete overnight by consuming this product but that some inflammatory joint conditions are eased by taking gingko. So that has been proven and, again, you need to make sure that the active ingredient is what it is said to be to make those tests stand up.

The Bullivant letter is one that, understandably, many pharmacists did not bother reading past the first couple of paragraphs, as they told me when I spoke to them about it. But it goes further and the case in point is Travacalm. But you could even move into hypericum, which is a natural herb based antidepressant. It is understood to have active properties, but it is also understood that you do not combine natural herb with pharmaceutical antidepressants. With the natural herb having an active property and it being available over the counter—the claims having been measured in terms of efficacy and the contents verified in terms of the composition of the product—you still do not want to mix it with a prescribed antidepressant. So that third level shows you a risk that, if such a product is not handled properly, there can be quite profound health consequences.

In my view, this is where we have the challenge—where you are seeing this overlap and potential cocktails of complementary and herb based medicines with prescribed medicines under the PBS. When those two come together, we have to have the smarts to recognise that that may not be in the best health interests of the patient. It also highlights what a difference that strata of products is from my occasional consumption of echinacea because a mate of mine told me it might help. This is where the argument needs to move, and that is why I support the review that the parliamentary secretary has announced.

This is not a one size fits all. There are different levels of claim. There are different medical consequences of consuming these products. There are risks associated with their overconsumption. There are risks associated if the active ingredient is in the product in excessive amounts, as in the case of Travacalm, where the excess active ingredient caused hallucinations and all sorts of horrendous health effects. There is that risk, but there is also a risk of combining a complementary medicine with a PBS medicine. We need to understand more about that. That is why these measures that we are debating today are necessary, important and timely. That is also why the review into complementary medicines in the health system, that Parliamentary Secretary Worth announced a couple of days ago, is crucially important.

My view is simple. If people offer herb based or complementary medicines but make no claim that they will have any medical effect at all, it should say that on the can: `Yes, have these. It might make you feel better. It might have a placebo effect. But we are not making any claims because we have not done any tests. You take your chances. It might make you feel better.' That is okay. Have it recognised that that is the level of activity. In the next level, where there is some medical effect, appropriate measured statements about that medical effect, backed up by testing, need to be there—above all, that there is no risk to the consumer. Then there is the third level where, if medicine is taken inappropriately or in volumes that are excessive, there are negative health consequences and that they could be particularly damaging when combined with PBS pharmaceutical products. We need to be far more rigorous about that. I see into the future a stratified level of regulation and disclosure, and this is a great step in the right direction. (Time expired)