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Thursday, 13 April 2000
Page: 16005


Mrs MAY (10:35 AM) —The purpose of the Therapeutic Goods Amendment Bill (No. 2) 2000 is to make a number of amendments to the Therapeutic Goods Act 1989. The bill enshrines in legislation the serious nature of manufacturing and distributing counterfeit or substandard drugs. The amendments introduce new offences and seek to clarify the offence relating to dealing with unapproved therapeutic goods and to punish suppliers who refuse to advertise their goods truthfully and ethically.

It is important to note that this bill addresses the deliberate production and supply of counterfeit therapeutic goods. The government has previously commissioned a review into the Therapeutic Goods Administration and key aspects of Australia's regulation of medicinal products. The intention of this bill is to act on some of those recommendations. The bill aims to promote and enhance the reputation of the therapeutic goods industry and to ensure that the health and wellbeing of the Australian and overseas consumers are preserved. Any government has a duty to protect the health and interests of its citizens from substandard products and unscrupulous operators.

Counterfeit drugs give false hope to consumers who may be suffering from a medical or possibly a cosmetic condition. In addition to protecting Australian consumers, as a government we must also work to expand upon Australia's reputation as a responsible, reputable export nation. Part of our international responsibilities as a signatory to the World Health Organisation Guidelines for the Development of Measures to Combat Counterfeit Drugs is to ensure that our legislation takes all necessary measures to prevent the production and distribution of counterfeit products. The World Health Organisation guidelines require that the legislation of member countries regulate the manufacture, importation, distribution, supply and sale of counterfeit drugs. The guidelines require Australia to ensure that this legislation is enforced and that our courts are able to impose harsh penalties on individuals or organisations that breach these laws.

The counterfeiting of drugs is a serious offence, and it is time it was recognised as such. By signing the World Health Organisation guidelines, Australia has clearly already agreed to the principles that the Therapeutic Goods Amendment Bill (No. 2) 2000 outlines. Now we must put these principles into practice. If we compromise our reputation as a responsible international citizen in relation to therapeutic goods, it will not only damage our pharmaceutical industry but also have flow-on effects for our other export industries which we rely on heavily.

But we also have a responsibility to those here in Australia. Turning a blind eye to substandard therapeutic goods would breach our responsibility not only to the upright members of the industry but also to public health considerations. If a consumer is using a counterfeit medicinal product with the wrong ingredients, an insufficient quantity of active ingredients or without active ingredients, they may be neglecting to use another product which would result in actual health benefits. The negative health consequences of neglecting to properly treat the problem could be serious. In short, this government does not believe that there are any benefits in allowing counterfeit drugs to be sold to the Australian people or exported to other markets.

The bill's second main amendment will clarify the confusion surrounding section 20 of the act which relates to the unlawful importation, exportation, manufacture and supply of unapproved therapeutic goods. The decision of the High Court in the case of Pan Laboratories Pty Ltd and the Director of Public Prosecutions highlighted the ambiguous nature of section 20. Section 20 has been interpreted differently by a number of judges, both at the initial trial and on appeal to the point where the High Court found that the problem could be resolved only through an amendment to that section of the act. By amending this section, the government will clarify the burden of proof on the Crown in relation to establishing that an offence has actually occurred and that the intention was there to commit the offence. This will prevent the future spending of taxpayers' resources in the courts and the burden on the judicial system in an attempt to interpret this ambiguous section of the legislation.

The bill's third main amendment seeks to enable the Complaints Resolution Panel to enforce the provisions of the Therapeutic Goods Advertising Code. This amendment gives the secretary an additional mechanism to cancel a supplier's goods from the Australian Register of Therapeutic Goods. This amendment applies if a supplier of goods advertises these goods in a way which contravenes the Therapeutic Goods Advertising Code and has not complied with a direction from the Complaints Resolution Panel to remedy that breach. Again, this amendment is about protecting the consumer, because it gives the Complaints Resolution Panel the power to enforce its decisions. It ensures that the panel is not a toothless tiger. If the public or another member of the industry identifies a problem or a hazard in the way a supplier is advertising or promoting its drugs to consumers, then this must be dealt with.

The advertising code is there to protect the public from misleading claims and unrealistic expectations of the outcome that a product can realistically deliver. Because it is often the case that consumers of therapeutic goods are suffering from a health ailment or a desire to change an aspect of their physical appearance, there are often emotions attached that may make them more vulnerable to purchasing the product than they would otherwise be.

Suppliers know that in these circumstances the attitude of `I'll try anything' often prevails. There have been instances where suppliers have used advertising to exploit that. More often than not, there are no miracle cures. The intention of this amendment is simply to ensure that a product lives up to the claims its promoters make. The amendment preserves a system of checks and balances as any decision to remove goods from the register is subject to review by the Administrative Appeals Tribunal. Therefore, reputable manufacturers and suppliers will not be affected, but the bad seeds in the industry will be weeded out. For the above reasons, and in the interests of public health and meeting our international obligations, I commend this bill to the House.