Mrs BRONWYN BISHOP (5:42 PM) —I rise to speak in this debate on the Therapeutic Goods Amendment Bill (No. 2) 2002 because I feel that there needs to be some clarification of what has really happened with regard to Pan Pharmaceuticals. I have been concerned that the debate seems to have turned from looking at the way in which regulation is first put in place and the agency then carries out its duties under the legislation to an almost exclusive discussion on the benefits or otherwise of complementary medicine.

I say at the outset that I think this is an unfortunate and unfair turn of events, because Pan Pharmaceuticals is a company which manufactured antibiotics, other strictly prescription drugs—that is, orthodox medicine prescription drugs—over-the-counter drugs and complementary medicines. All manufacturing of all those things requires that the code of good manufacturing practice be followed. It is the suspension of their licence to manufacture which is now taking an enormous toll on thousands of small business people and perhaps on the employment of anything up to 5,000 individual Australians.

The fact of the matter is that there were announcements being made on the radio which I heard myself which were saying, `You don't have to worry about any prescription drugs because they are not included in the recall.' In fact, two products, doxycycline, which is an antimalarial drug, and erythromycin, an antibiotic, appeared on the recall list. But the significant thing about the drugs that were by and large, as I understand it, manufactured by Pan Pharmaceuticals is that for the most part they were all exported, and there is no power under the TGA to recall drugs which have been exported.

I sat on the original inquiry of the Public Accounts Committee which resulted in the establishment of the therapeutic goods legislation and the body which polices the proper registration of drugs, over-the-counter products and complementary medicine. Prior to that establishment, the way in which exports were handled was that each state government would issue a certificate virtually of good manufacture and they were then permitted to export. It was felt that there was a need for a centralised Commonwealth body which could then speak with authority and vouch for the safety of the products that we were exporting. In fact, those drugs, antibiotics included, that are exported cannot be vouched for. They probably sit on the shelves in Singapore, Malaysia, New Zealand and Thailand, and to that extent I think it was unfair for the commentary and the debate to focus solely on the question of whether or not complementary medicines could be vouched for, because the responsibility is to vouch for all of them. Over-the-counter products and the drug that was manufactured and supplied and then caused people to be very ill, the anti travel sickness drug, was in fact a pharmacy only product; it was not a complementary medicine product at all. To the best of my knowledge, there have been no reports of adverse side effects from any of those complementary medicines. That is not to say that it is not proper that because of their failure to meet the manufacturing code there should have been a recall.

I went a little further and took a look at the Australian Institute of Health and Welfare report for 2002 where it deals with the number of adverse incidents from drugs that are dealt with in hospital. The most up-to-date figures they have are for 1997-98, where the number was in fact 53,368 incidents from orthodox medicine drugs. So I think the most important aspect in the amendments that the government is moving is a very sensible and very good one, and that is that it is necessary that the manufacturer be a fit and proper person. I think that is very important change to make.

When we look also at part and parcel of the reason for the establishment of the TGA—and incidentally a therapeutic good includes a device as well as medicines—one of the things that was thought to be important was that there be full cost recovery, so people wanting to bring new orthodox medicine drugs for sale into Australia obviously have to prove those products. It is not enough to say, `Well, they approved it in the United Kingdom,' or `They approved it in the United States or Canada'; they have to say that they approved it here in Australia. When drug companies want those new drugs to be approved, their final aim is to get them on the pharmaceutical benefits list because that is the way in which they can ensure that they get their volumes of sales. So it is very important, when we are looking at the legislation and thinking about the whole question of what Pan has done, to note that it has affected the whole industry—that is, antibiotics and other orthodox medicine products and over-the-counter products such as the Travacalm product as well as complementary medicines.

I understand that the government is to set up an inquiry to deal with complementary medicine. I think it is of fundamental importance that there be good consultation between the government and those people who make up the complementary medicine industry. Not to have that consultation would be most unfortunate because it would further exacerbate a lot of the angst that has been around in the community where every person prejudiced against complementary medicine has been able to have airplay. The fact of the matter is that we are seeing more and more cooperation between complementary medicine practitioners and orthodox medicine practitioners. You will see them working together and respecting each other's knowledge, and that has been to the benefit of patients.

The other point I would like to make about the importance of the TGA with regard to the registration of new drugs that come into Australia is that, aside from wanting to get the volumes of sale and therefore get onto the pharmaceutical benefits list, drug companies also have a problem with owning a patent. I am relying on my memory, but I recall that there was an extension to the life of patents granted because it can take, say, seven years to actually get registration and seven years of the patent time has already gone, so the effective life of the patent that they have to make their profits from has been limited. If my memory serves me, it is now 25 years, but someone will correct me if I am wrong, I am sure.

New orthodox drugs have to be subject to a lot of rigour because they are unknown. I can recall that a particular drug came into Australia and was used by people suffering from Parkinson's disease. It was registered here and was being used, but then it was taken off the market in Australia. It remained on the market in New Zealand and people could import it from there. It was found that it resulted in, I think, liver disease. Again, if I am wrong I am sure someone will correct me. What I am saying is that when new drugs are brought in it is very much in the interests of people who are in need of new drugs that there be very strict rigour.

Complementary drugs, on the other hand, have been around in most cases for decades—and in some cases for centuries. They are unable to be patented and that is why there is much less interest from manufacturing companies—because the profits are not there to be made in the way that they can be by introducing a new drug. There is nothing wrong with making profits from a new drug. There is nothing wrong with having an incentive for new ones to come on stream. It is, indeed, desirable.

I want to commend this bill to the House. I believe that the amendments that have been moved are timely, particularly the requirement for the manufacturer to be a fit and proper person. But I did want to make the point that Pan Pharmaceuticals failed in all three categories of therapeutic goods. It failed for orthodox medicine—prescription-only medicine—for over-the-counter, pharmacy-only medicine and for complementary medicine. I think it has been an unfair debate in that it has focused on prejudice against complementary medicine by people who seem to have a bias towards orthodox medicine. But as I said before, I am delighted to see that more and more of these old prejudices seem to be slipping away.

I would like to conclude by mentioning one particular product which has also come in for some discussion—and that is folic acid. Folic acid is the product which is recommended for use by women of child bearing years to prevent spina bifida in their children. Spina bifida is a terrible thing which can result in early death for the child. It can result in the child not being able to walk and being disabled. For many years naturopaths and practitioners in complementary medicine were recommending folic acid. In those days orthodox medicine would not have any part of signing on to folic acid being a preventative for spina bifida. It was not until a study in the United States ascertained just how much money hospitals were spending on looking after spina bifida children that they did research into folic acid. Now it is accepted by all. Orthodox medicine says that folic acid is an important therapeutic good to take to prevent spina bifida. So it is a case where complementary medicine practitioners were recommending its use and subsequently orthodox medicine came on board as well.

There was some discussion in the media, after the Pan Pharmaceuticals recall, about a new test that had been brought in which showed that some folic acid capsules had not met a new standard of strength. What an irony it is that, the benefits having been denied for so long, people now realise its value and there is proper scrutiny.

There is one further thing that I would like to say in this debate, and that is that I think the Therapeutic Goods Administration should, indeed must, set up a regime of spot checks. It is no good saying, `We're coming along,' and having them clean up the factory and get everything spick-and-span so that the audit that is carried out is satisfactory. That is necessary as well, because you need the assistance of staff to carry out that audit properly. However, spot checks are essential. Had spot checks been carried out, they could well have found the person sweeping up the product from the floor and putting it back in bins, or they could have found that the machinery had not been properly cleaned. There are probably many more tales to tell about Pan. Perhaps time will tell. In passing this legislation we are taking the right course but I do say that there is a need for spot checks. I also say that there is a need, with regard to this inquiry which is now going to be held by the federal government into complementary medicine, for proper consultation with the industry and government before names are announced so that the people who are involved in the industry can be confident that it will be a fair inquiry.

There are many people in Australia who use complementary medicines. And people pay to buy those medicines. They are not subsidised by government. They attract GST. I think the amount of GST collected is something in the vicinity of $130 million. It is an important industry, and it is one that a lot of people access when they do not get satisfactory outcomes from orthodox medicine. They may find that their wellbeing is enhanced by the use of complementary medicine. I think it is important to remember that and put aside biases that some folk might have when other people find that it benefits them and gives them wellbeing.