Ms GRIERSON (12:09 PM) —I rise to support the Therapeutic Goods Amendment Bill (No. 2) 2002. The amendments to the original 1989 act and the Broadcasting Services Act are much needed and long overdue. In fact, the Australian public has the right to ask why the government has not overhauled this bill before today. Given the recent Pan Pharmaceuticals fiasco, they should be asking this government a lot more about what it is doing to regulate industry sectors such as this one and what it is doing to look after the interests of consumers generally. How embarrassing for the government it is. Government speakers in this debate are trying to push that blame somewhere else, but certainly the buck does stop somewhere, and it stops with government. However, the amendments put forward do improve the definition of what therapeutic goods are and how they can and should be advertised. The amendments do increase the application of the regulations under this act to all therapeutic goods. These are certainly all measures that are needed to increase consumer protection, industry certainty and public confidence that health needs will be looked after properly.

Under the current legislation, some complementary products can be regulated as food and not as medicines, which means that those products are not subject to any premarket assessment or postmarket regulatory surveillance. Unless a product is specifically identified as a supplementary medicine, the checking of these products is not at all rigorous. But we all know now that in the case of one particular manufacturer, Pan Pharmaceuticals, even those products listed as therapeutic goods were not rigorously monitored and were not subjected to quality controls as the public would have expected them to be. Unfortunately, many people in Australia have suffered quite serious health consequences because of that.

Under these changes to the legislation, products will be defined as therapeutic goods and they will be subject to a fuller range of regulatory and advertising offences. Consumers rely on information presented to them in advertisements. They should not have to be scientists or health professionals to assess advertising claims. They should have confidence that government has already done that for them. Although governments obviously cannot check the claim of every advertisement, knowing that there are strong penalties for deceiving consumers certainly acts as a deterrent to deliberate misrepresentation or misinformation. In that regard, these amendments are particularly needed.

Further amendments to the Therapeutic Goods Act 1989 have been introduced because of the Pan fiasco. However, having only seen them for the first time a couple of hours ago, I register my protest against a government that needs to hastily put forward changes because of its own failure to be an effective consumer watchdog or industry regulator. We hope that they have got it right. But, on preliminary assessment, these amendments do seek to stop manufacturers who seriously breach the act from regaining a licence after those breaches, and they do provide for a fit and proper person test—that is a very difficult one to ensure, isn't it? Further amendments increase the maximum penalties for the failure to comply with standards, the falsification of records required by the TGA, the misrepresentation of products conformity and the counterfeiting of therapeutic goods test results. These amendments also introduce new labelling laws that ensure manufacturers' details are placed on packaging.

The intent is there but let us hope that these amendments go far enough. As we have seen time after time, with this government it is a case of dealing with trouble long after trouble has been visited upon ordinary Australians. We have already experienced the One.Tel and HIH collapses and watched all Australians being caught up in the fallout of corporate mismanagement through higher insurance payments and the loss of community services. After those failures the public would be entitled to think that this government is becoming a little irrelevant in protecting the interests of employees, shareholders and consumers. But we would have hoped that health needs were absolutely paramount. The royal commission into HIH was critical of government's failure to properly resource its regulators, and I think we all feel that TGA should not be a scapegoat. They have responded properly in their role, but perhaps they did not have the resources to do what we would have expected them to do. It is up to government to make sure that our regulators have adequate resources, guidelines and the safety and comfort of legislation that guides them in their monitoring processes.

It comes as no surprise when we consider that the highest taxing government in Australia's history thinks that industry self-regulation is the way to go. Trust is a wonderful thing but, unfortunately, trust is not what regulates industry. It certainly is about having processes in place, and self-regulation has been proven to fail. It is fine if companies and industry representative bodies are willing to invest dollars and technical and human resources into quality assurance and accountability processes, but they are not legally required to at this stage. It is really a trust factor. That is not good enough. Unfortunately, the Pan fiasco, coupled with the HIH debacle, does cast serious doubts on the effectiveness of self-regulation and on this government's ability to properly resource and manage the regulation, monitoring and quality-control processes in any industry in Australia.

The therapeutic goods industry, which we are dealing with today in this legislation, does manufacture and distribute complementary health care products. No matter what you think about the value of those products to health care and wellbeing, the reality is that 60 per cent of adults in Australia regularly use those complementary medicines. The complementary health products sector is worth $1 billion to our domestic economy. It generates exports worth $200 million. That sounds like a sector about which the government needs to be very proactive.

Everyone saw how extensive these products are when they saw the recall advertisements in newspapers—pages and pages of fine print, with the recall list jumping from 200 products to 1,700. I guess that is what prompted us all to go and look in our cupboards; and, yes, we did find them, didn't we? What products were recalled? They included the many herbal and vitamin supplements that you find in almost all medicine cabinets and kitchen cupboards in Australia. Claims about these products' usefulness range from assisting memory, warding off the common cold, increasing energy levels for people on vigorous exercise regimes, reducing the effects of stress or depression, and generally prolonging life and preventing health problems.

Like 60 per cent of the Australian public, I am a real believer in some of these products. I have bought the student formula for my own children when they have been studying for their HSC; I have used vitamins to try to protect myself from the fallout of the stresses of a busy lifestyle, and I support those who look to alternative methods to treat medical conditions such as depression, memory loss and, of course, more serious conditions as well. For many people, these products provide security and comfort in their daily health regimes. If they and their doctors feel these products may be doing some good, then they certainly should use them, but they also should have the security and comfort of knowing that there is some quality control and regulation of those products.

I do think we have to acknowledge that the TGA did find the problem, and for that we are very grateful. It was notified promptly, but government failure was evident. There was some slowness to act, there was some mishandling of the notification to the industry and the public, and there certainly was a catch-all policy that had some serious implications for local businesses, including those in my own region of Newcastle. There are not many companies that manufacture to the extent that Pan did, so when companies are outsourcing to other companies such as Pan, they do not have a great deal of choice. They expect the biggest ones to be the best ones. It is appalling that so many companies have been let down.

In my electorate, a company called I Think Naturally manufactures seven products, and two of their products were on the recall list. That company designs very specialised products to a very specialised formula, and it builds its reputation on its formula and its product. It designs the formula and then outsources to another company—not Pan—to manufacture the products. So the products are assembled by someone else. Then that company sends the products on to Pan to be put into capsules—that is all. Under the process that TGA has in place, the company that assembles the formula has to do rigorous testing and record the results before the product is sent off to Pan to be put into capsules. When it returns to the manufacturer it is again tested and those results are logged with TGA. Then it is given back to the original designer of the product for distribution and marketing. One would hope that all those checks and balances would have been in place and that Pan, which only puts the product into capsules, could not have contaminated that product. Unfortunately, we know that that may not be so. My local company, so far removed from Pan but so vulnerable to the failure to regulate and audit the performance of Pan, now faces serious economic loss. Do they carry insurance for that? No, I am sorry, but small business cannot afford to cover insurance for economic loss. Not any more.

TGA did have concerns about Pan Pharmaceuticals logged in January. One would think, if they had concerns about Pan, that they might have looked at the range of companies that would be affected, looked at the processes and perhaps tried to isolate the most serious ones. The other things that companies are asking me is: what does a voluntary recall mean? And what assurance is there for the public in a voluntary recall? There are some serious concerns about voluntary recalls and just what the responsibility, accountability and liability will be. You will know that many people are not seeking to send these products back, but many products have a two-year shelf life and one wonders if, down the track, we are going to see a continuation of problems caused by the failure to regulate this industry correctly. We do not know how the recovery of loss will be managed.

In our region, where we do have good communication and media, we were not visited with largesse from the government. Our media were not given the advertised recall. It was up to them to advertise it themselves out of civic mindedness. I have to say to the government: in Newcastle we do not wait for Cobb and Co to bring our newspapers anymore. The Newcastle Herald is delivered every day as a daily newspaper, to the whole of the region, and has been for longer than I have been alive. But apparently it was very much on government's mind to inform only capital cities about this recall list, and regional Australia—not on the radar screen—missed out again. In Newcastle, the Herald did advertise a list. I have spoken to the editor, and I am told they had to get it off the web site. It was not in a form that they could download easily so they were spending a lot of time typing that list, with no assurance that they had got it right. Five days after the recall list appeared in capital city newspapers, the government did advertise in the Newcastle Herald—five days after the rest of Australia found out about it.

Another issue of concern is that people who do not buy these products might think it is not important to them and that, if they do not rely on those complementary health products, maybe it is not something that affects them. But looking at the trading of the Pan shares, we may think, `All those people out there who are in superannuation, where are your shares invested? Is this going to affect you?' But they really will not know. The public of Australia do not know the fallout of this Pan Pharmaceuticals fiasco. Certainly in small businesses, small pharmacies and health stores, one would hope that their margins are sufficient to protect their employment of personnel and their income. But we know that particularly in small health stores there may be job losses—and that is the reality of it.

This legislation does arise from an actual threat to public health and from a real need to regulate industry—and to regulate an important Australian industry. After listening to the speakers on this debate, it seems the government are looking around to see whom they can pass the buck to, but they are at the end of the responsibility queue and must accept responsibility for their regulation failures. Fortunately, we do have amendments before us today; but, again, it is too little too late. This legislation is still not enough to give the Australian public confidence that regulation and audit processes will be there to ensure that public health is assured to all consumers, when purchasing and using therapeutic goods. We would hope that witch-hunts will not arise from this legislation and that proper processes will be followed. We would also hope that there will be a follow-up to review the implementation of this legislation and that that review will be done rigorously and in a way that informs the public. Specialist committees and expert reviews are fine, but the public have to be informed so that their confidence can be restored in an important sector of Australian industry. I support this bill.