Mr JENKINS (1:02 PM) —I rise in support of the second reading amendment moved by the honourable member for Bruce, Mr Griffin, to the Therapeutic Goods Amendment Bill (No. 2) 2002. This debate is timely. Whilst the measures contained in this amendment bill are worthy of support, at the time of the initial motion for the second reading of the bill perhaps they were not, in the public mind, of such great moment as they should have been. I have had the pleasure of talking in debates about amendments to the Therapeutic Goods Act on a number of occasions. I think the importance of the measures contained in an act like this has perhaps been a bit lost on the wider community. Regrettably, the events that surrounded the fiasco that is Pan Pharmaceuticals Ltd have perhaps focused the minds of the wider community on these issues.

In the past I have stressed the importance of having a regime that deals with making sure that what is produced, registered and made available for purchase is safe. Of course, that is the driving motive of not just those of us on this side but the House in general. The arguments we have had about the speed of the response and the measures that perhaps were not taken earlier on are now in the political arena, and they are important in themselves in that there needs to be a reminder and the government needs to be accountable for its actions. The most important outcome we can have from the amendments that arise out of this piece of legislation before us at the moment, and the amendments that will be moved in the consideration in detail stage, is a more direct response to contemporary events.

The current circumstance that has caused the great discussion is, in the main, to do with a manufacturer that produced mainly complementary medicines or alternative medicines—whatever term we want to use as the vernacular. I think this incident has made sure that people understand that the standards we expect of things listed on the PBS, or that are seen clearly as medicines that require a doctor to prescribe and a pharmacist to dispense them, should apply to all forms of therapeutic goods. The discussions that we have had about the events of the past few weeks to do with this manufacturer, and also about the events of the last several months, are to do with that concern.

It is interesting that it was the original therapeutic goods legislation that ensured that manufacturers of complementary medicines came under the same standards and regime expected of other aspects. If we put that in context, I think the act is from about 1989 or 1990; I do not think it became operable until about 1991, so that is only a 12-year period. It is proper that we review the outcomes of pieces of legislation like this. I do not think we should get too het-up if people get excited and want to criticise what is happening under the legislation, because it is right that the piece of legislation should be open to review.

Originally, this type of manufacturing was brought in under the Australian Code of Good Manufacturing Practice. As I understand it, this has now been included in the Australian Code of Good Manufacturing Practice for Medicinal Products. The TGA's audit procedures, required to ensure that the code is followed in manufacturing practice, led to the discovery of the grave shortfalls in the processes used by Pan Pharmaceuticals.

Other issues need to be raised. The Therapeutic Goods Administration was alerted to concerns about what was happening at Pan because adverse reactions had been experienced after the use of some batches of the drug known as Travacalm. It was appropriate that the TGA—in February of this year, I think—acted to recall that drug. Subsequently, an audit revealed a whole host of practices that needed to be condemned, if the audit is absolutely accurate, such as the substitution of different cartilage products like shark cartilage and beef cartilage and the fact that active ingredients were present at either above or below the levels stated to be in the drug. There was a list of a whole host of incidents that are shameful to think of in relation to a company that had developed a great deal of market share. It is ironic when you have a major investor in health involved—Mayne Health had bought out one of the herbal medicine companies which then had Pan producing their products on licence.

There was discussion earlier in the debate about the extent of this industry. That is why this debate is so important. Many consumers, for a whole host of reasons, have been drawn to use the types of products we are talking about, which can be described as complementary medicines, herbal preparations, vitamin supplements and the like. In the debate the honourable member for Bonython has discussed the perhaps over-the-top claims that are made for some of these drugs. In some quarters there is a great deal of scepticism about whether these products are legitimate and whether they should have the status that they have developed. In the nineties, when I chaired the House of Representatives Standing Committee on Community Affairs, we did an inquiry into the prescription and supply of drugs, and the committee visited a manufacturer of herbal preparations. I only relate this story because it relates to the issue of scepticism. The particular member I am about to talk about has not been in this place for a while and I am sure that he would not mind me relating this story.

The former member for Corinella was on the committee—not the member for Bruce, who was formerly the member for Corinella, but another former member for Corinella in this place. We were at this particular manufacturing place and we were being shown elements of the manufacturing. Ingredients were being ground in a mortar and pestle and it was explained to the committee that it was not only the ingredients themselves that were important but also the synergies in the use of the mortar and pestle and in the manufacturing. My colleague on the committee was rather ungracious about this revelation, using an expression that is unparliamentary and that relates to a substance we usually avoid when out in paddocks. It was highly embarrassing to me as the chair of the committee. That particular member for Corinella had the grace to quickly leave the laboratory so that further discussion of his comment and other comments did not continue.

Raising that aspect about these preparations goes to some of the issues we confront which go beyond, perhaps, the way we have traditionally looked at substances that people use which they believe have a positive outcome and the types of tests we have used to test their efficacy. That is the challenge that confronts the TGA, and we have to acknowledge that. It is important that our baseline not only relates to the safety of any preparation or product which is marketed but also assists, like we do with prescription drugs, with the information that is made available. I acknowledge that in totality the reasons for this original bill, the response to recent events and the additional amendments that we made in the consideration in detail stage go to a lot of those issues of information—making the consumer aware of what is actually involved in the manufacture of the things they are purchasing. It is important that when we review aspects of the Therapeutic Goods Act we provide people with information with which they can make informed decisions. So it goes to information about ingredients and to setting the types of claims that can be made for product efficacy and the reasons for taking a product.

The latter amendments have come about from difficulties, especially at the time of the recall of the thousands of products, which revealed the important need for the source of manufacture to appear on products. That would have made the task of administration a lot easier not only in recalling products but in the public portrayal of the situation. There was a degree of confusion. I do not argue with the caution that is exercised by authorities such as the TGA but, at a time when the public consequences were uncertain, the case was put that there was a need to act as quickly and promptly as possible. There has been discussion in this debate about the measures that were taken over the several months during which Pan was subject to audit. Other measures that will be raised through amendments in the consideration in detail stage concern the character of people that are involved in the industry. That is in direct response to some of the aspects of the principals of the current public incident. It is also important for the reassurance of everyone—manufacturers who contract out, manufacturers who operate under licence, and consumers.

I wish to take the opportunity in this debate to again stress the importance of those people who give consumers advice. They must be provided with sufficient information. Why do I stress that point? Because some of the information that we provide to people needs to give recommendations that are more detailed and more scientific. There is always difficulty with the form in which we give information to the consumer. I stress that I want the consumer to be in a position to make an informed decision. I understand the limitations. Because of the complex nature of some of the products, the claims that can be made about these products may not be in any way intelligible. A very important argument about all products under the Therapeutic Goods Act is that we should be clear on what they do. That is why, especially with medicines that are listed through the PBS, we have doctors involved in prescribing and pharmacists involved in dispensing.

With over-the-counter drugs—drugs that can be bought off the shelf—we believe that we have the ability and capacity to do that in a safer manner, but we still need to make information available that allows for informed decisions. I note that the Pharmacy Guild and the AMA on behalf of the medical profession have done a lot of work in making sure that their members are made aware of information. They have made sure that their members take into account the effects of complementary medicines—which have been the main point of discussion in this debate—on the range of treatments that might be involved in patient care.

It is important that we realise that this is an industry that, as I said earlier in the debate, has developed a market share. Consumers are voting by way of their purchases. As was clearly illustrated by the member for Bonython in his contribution, we have to ensure that over-the-top claims are not made. On some occasions the placebo effect is the greatest advantage of some of the products people take. There has been great discussion about whether, if that is the way in which these things have some positive outcome, that is all that should be claimed in the label. By physiological investigation it is often very difficult to ascertain what these drugs cause. There is no doubt that, in some cases where there has been proper research into the effects of substances, they are seen to have a positive effect which cannot be clearly explained by some biochemical or physiological reaction.

As I indicated, I support the comments that were made by the honourable member for Bruce in leading the debate for the opposition. I am sure that we will look at the measures that arise out of government action, especially over the incident involving Pan Pharmaceuticals, to continue to monitor the way in which the present legislation operates. We will look at the way in which we can perhaps help the TGA in their monitoring and policing under the Therapeutic Goods Act to ensure that we have in place a regime that leads to the expressed aims of the system. Those aims are to ensure that when therapeutic goods of any type are marketed and provided to people they have been assessed, their safety is assured and there is sufficient information given that will ensure that there is an understanding by the consumer.

It is the responsibility of legislators to ensure that we put in place an administration, laws and regulations that over time can return confidence to people in products that have developed a great following. As I said from the outset, I understand the difficult situation the administration finds itself in. It has a need to be cautious and sure in the actions that it takes because of the way in which manufacturers might seek remedy if hasty action is taken. But the important thing is that we have a responsibility to ensure that we put in place an administrative framework that enables them to do their work in the sure, confident and timely way that the community expects.