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Thursday, 13 April 2000
Page: 15997

Mr GRIFFIN (9:58 AM) —As with the previous Therapeutic Goods Amendment Bill, the Therapeutic Goods Amendment Bill (No. 2) 2000, while non-controversial, makes some important and welcome improvements to the Therapeutic Goods Act which will benefit consumers and the medicine industry alike. Firstly, the bill makes it an offence to deliberately manufacture, supply, import or export counterfeit therapeutic goods. These offences, which not only undermine patent protection for therapeutic goods but place the health of the public at risk, up until now were prosecuted under the Therapeutic Goods Act for the lesser offence of manufacturing, importing and exporting therapeutic goods not included on the Australian Register of Therapeutic Goods.

While this change is most welcome and is supported by Labor, it has been a little slow in making it onto the books. The World Health Organisation originally raised the issue of counterfeiting in 1988. Since that time, it has conducted workshops on the issue with member states. In May 1999, it passed a resolution that called on governments to expand their efforts to ensure effective drug regulation. Our government expressed a high level of commitment to the WHO principles of anticounterfeiting at the time and yet it has taken 12 months to put that commitment into action. If you take into account the fact that the November 1994 GATT TRIPS agreement, to which Australia is a signatory, imposed obligations on members of the World Trade Organisation to provide for criminal procedures and penalties to be applied, at least in cases of wilful trademark counterfeiting or copyright piracy on a commercial scale, this legislation has taken even longer to appear.

Why the need for speedier action on this point? Counterfeit products cost lives both in developed and, more particularly, in developing countries. While the word `counterfeit' implies a precise imitation of a genuine product, in the case of medicines this is often not the case. Counterfeit products may just have been repackaged and sold on or, at the worst end of the spectrum, the counterfeit medicine may contain entirely different and sometimes poisonous ingredients. In the middle of the range, counterfeit products may include the right ingredient at a lower—subtherapeutic—dose. This can be a particular problem with products used to treat infectious diseases, such as antibiotics, where using the wrong dose can lead to the development of antibiotic resistance in the community. In recent times, antibiotic resistance has become a major concern in developed countries, including Australia, where people are now dying from bacterial infections that can no longer be treated by antibiotics.

On the far end of the spectrum, one particularly devastating example of the effects of counterfeit medicine, recounted by the International Federation of Pharmaceutical Manufacturers Associations, involves a tragedy that occurred in Haiti. In this case, 30 children died after ingesting counterfeit antifever medication that contained diethylene glycol, an industrial solvent used in antifreeze. In Nigeria 109 children died after taking a counterfeit medicine sold as medicinal syrup but which contained the same solvent.

In Australia we have been lucky because there have been no such tragic incidents to date. While counterfeiting of medicines is not a major problem in Australia, it still represented 20 per cent of the 200 criminal charges laid in relation to offences involving therapeutic goods between 1991 and 1996. Of concern is the fact that these charges related specifically to offences of illegal export—that is, Australian companies selling substandard, unregistered products to countries such as Vietnam and New Guinea, countries which do not have the same rigorous regulatory standards that we enjoy. These are the very countries that the WHO is trying to protect. Dr M. Ten Ham, chief of WHO's drug safety unit, has said, `The less a country has an inspection and control system in place, the more likely you will find counterfeit drugs on the market.'

Australia's proximity to such countries makes it a handy base for unscrupulous manufacturers to manufacture and export these products. We have an obligation to ensure that these manufacturers are shut down and penalised accordingly and that countries that are unable to afford or resource the type of excellent regulatory system we have are protected.

Counterfeiting of medicines also has financial impacts—both on the health system and on our medicines industry. It is estimated that the trade in counterfeit medicines costs the international pharmaceutical industry billions of dollars per year, a cost that eventually has to be borne by the consumer. One of the major improvements gained by this provision in the bill is the introduction of severe penalties for this offence. Under the previous legislation, where people were prosecuted under the offence of dealing with unapproved therapeutic goods, individuals found guilty faced a maximum penalty of $26,400. On the passing of this bill, the maximum penalty for an individual who intentionally manufactures or supplies in Australia, imports into Australia or exports from Australia counterfeit therapeutic goods is five years imprisonment, a fine of up to $55,000 or both. For a corporation the fine may be up to $275,000. Counterfeiting of medicines is certainly an issue that deserves more attention than it has had so far and, to this end, again I repeat the opposition's support for this provision.

The second provision clarifies the offence of dealing with unapproved therapeutic goods. I will not dwell on this except to say that anything that strengthens this law and provides greater protection for the community is a good thing.

I would now like to move on to the third provision of the bill that relates to the advertising of therapeutic goods. This provision gives some teeth to the Complaints Resolution Committee, the body responsible for dealing with complaints arising from breaches of the Therapeutic Goods Advertising Code. Rather than giving companies that do not comply with the code and the rulings of the Complaints Resolution Committee what is essentially a slap on the wrist, this new provision will allow the Secretary of the CRC to cancel the registration or listing of the therapeutic good in question. In other words, the offender will no longer have a product to market.

With the massive growth in the use of non-prescription, particularly complementary, health products, this is a very important provision. Recent surveys have shown that up to 37 per cent of Australians now use complementary medicines every two weeks, and 60 per cent of the population use them every year. On the whole, this is a good thing. If these products work—and the continued growth in sales indicates many must—then this shifts some of the burden off the Pharmaceutical Benefits Scheme and Medicare. However, these are active medicinal products for human consumption and, as such, they must be regulated in some way to ensure that they are safe and used safely.

In acknowledgment of this, the government has established a section within the Therapeutic Goods Administration to deal specifically with complementary health medicines. In addition, the new Therapeutic Goods Advertising Code, which was released last week, has been reviewed to take into account the issue of advertising these medicines. Again, in recognition of the growing popularity of these products, these are good things and provide a level of protection for consumers. Unlike pharmaceutical products, complementary medicines can be advertised to the general public. The new code, while allowing these products to make claims about their efficacy in the treatment of the symptoms of certain diseases and conditions, also stipulates that these claims must be supported by evidence.

As is the case with pharmaceutical products, members of the public or other stakeholders are able to make complaints about the advertising and promotion of complementary health care products if they believe such advertising is false or misleading. These complaints are heard by the Complaints Review Board and, if upheld, the manufacturer concerned has, until now, faced at most a fine, withdrawal of the offending advertising, and/or a requirement to print retractions. With the addition of the third provision of this bill, the Complaints Review Board now has real powers to punish manufacturers who are at the very least making snake oil claims and, at the worst, putting people's health at risk.

While direct health claims for complementary health medicines must be supportable by good evidence, I would also say that the tone of the advertising must also be taken into account. Over the last year there have been several examples of complementary health medicines which have been promoted in an almost clinical manner as if they were, in fact, prescription products. This gives consumers an impression of scientific support for the product that may not exist.

Prescription medicines have to go through rigorous testing procedures, including many years of clinical trials, prior to being allowed on the market. Complementary medicines do not, and should not mislead consumers into believing that such scientific heritage exists. So I would urge both consumers and regulators to look at not only the words used in advertising and promotion but also the tone and implications.

The other issue I would like to touch on briefly is labelling of complementary health medicines. As I mentioned earlier, the continued growth in this market is an indication of the efficacy of some of these products. I am no scientific genius, as the member for Maribyrnong would no doubt concur, but what that says to me is that if they work, they are actually doing something in the body, they have an active ingredient. That being the case, they are also likely to have an effect on or with other complementary or prescription medications being taken.

Consumers must be made aware of the possibility that these interactions may occur and that they may lead to adverse reactions. There have been a number of examples of this outlined in the international and Australian media recently. St John's wort has actually been shown in published clinical trials to be effective in the treatment of the symptoms of anxiety and depression. However, it seems that this herb is metabolised in the body in such a way as to cause dangerous interactions with a number of prescription products.

The Therapeutic Goods Administration has posted a warning on its web site to doctors and pharmacists on these interactions and recommended that St John's wort not be taken with the following medicines: HIV protease inhibitors; HIV non-nucleoside reverse transcriptase inhibitors; Cyclosporin, to prevent organ rejection in transplant patients; Warfarin, a blood thinner; Digoxin, for treatment of heart problems; theophylline, for treatment of asthma; anticonvulsants; oral contraceptives; antidepressants; and migraine products. That list really says that, though there are matters of concern in the context of using St John's wort, St John's wort does actually have an impact on the body. This is not to say that people should stop taking St John's wort if it is working, but they should discuss with their GP or pharmacist which of the other products they should stop using.

Another example of this was a recent warning by the Food and Drug Administration concerning a Chinese herb called quon dong. People with diabetes should not take this herb as it causes adverse reactions when taken with many diabetes medicines, no doubt a problem for the member for Maribyrnong. These examples raise two issues. Firstly, why aren't potential drug interactions or warnings placed on the labels or packaging of complementary health medicines in the way they are on prescription medicines? Secondly, how are we going to ensure that health professionals and their patients feel comfortable and able to discuss the use of complementary medicines as well as prescription medicines?

I believe that the government and industry must act to address the first issue, and quickly. As regards the second issue, I believe pharmacists have a crucial role in counselling their customers about the medications they are taking and whether taking certain combinations is safe or not. Indications are that doctors are now becoming more knowledgeable about complementary health medicines. This is encouraging, but it is also their responsibility to proactively ask their patients questions about the use of these medicines. Surveys in the US have shown that most patients feel uncomfortable about discussing complementary health matters with their doctors, fearing that doctors will be dismissive about the issue. Whether they are or not, doctors have the responsibility to ensure that the health and safety of their patients come before their own beliefs and opinions.

These concerns aside, I have been impressed with the way in which the majority of complementary health medicine manufacturers have worked with us—government and consumers—to ensure that their products are used and promoted safely. I congratulate the industry on its work and sincerely hope that the productive relationship developed between them and government continues. The greatest beneficiaries of this cooperation are consumers, who will be able to make informed choices about their health care knowing that the regulatory system that exists will protect their health and safety. On that basis, I commend this bill to the House.