Secretary of the Department of Health, Disability and Ageing v Key Promotional Products Pty Ltd

This case arose from the import and sale of rapid antigen tests during the COVID-19 period, shortly after self-administered COVID-19 rapid antigen tests had been approved in Australia. The Secretary of the Department of Health, Disability and Ageing sued Key Promotional Products Pty Ltd and Mr Craig Shane Harding in the Federal Court.

The commercial conduct was straightforward but serious. Key Promotional admitted importing 255,000 RATs into Australia, supplying at least 240,720 of them to customers in Australia, and making 2,303 false or misleading representations that the products were of a kind included in the Australian Register of Therapeutic Goods. The Court recorded that those representations included statements that the products were "TGA approved" or the attachment of a record of a medical device that was in the Register.

The products mattered because they were not treated as ordinary consumer goods. The Court said each RAT was a "medical device" under the Therapeutic Goods Act because it was intended to diagnose COVID-19 in humans. That brought the products into a national regulatory scheme concerned with quality, safety and efficacy.

Mr Harding was not the company itself, but he was still exposed. He was an employee of Key Promotional and married to the company's director. He admitted that by 4 January 2022 he knew the essential matters that made up the company's contraventions and that he aided, abetted, counselled or procured them.

The case also had a procedural twist. After the agreed facts were signed, Key Promotional went into liquidation. That meant the Secretary needed the Court's leave under the Corporations Act to continue the proceeding against the company.

The reasons identify the Therapeutic Goods Act 1989 (Cth) as the central statute. The Court referred to the Act's purpose of establishing and maintaining a national system of controls relating to the quality, safety and efficacy of therapeutic goods, including medical devices used in Australia.

The Australian Register of Therapeutic Goods, maintained under s 9A, was central to the case. The Court explained that a person contravenes the Act if they import into Australia or supply in Australia a medical device that is not of a kind included in the Register in relation to that person, unless one of the provisions in s 41MIB(1)(b) applies. In this case, the declarations were made under s 41MIB(1)(a)(i) for importation and s 41MIB(1)(a)(iii) for supply, and the declarations expressly recorded that none of the provisions in s 41MIB(1)(b) applied.

The representation conduct was dealt with under s 41MLA. The Court made declarations that Key Promotional contravened s 41MLA(1) and s 41MLA(2)(a) by making false or misleading representations that the medical devices were of a kind included in the Register. The Court accepted that the admitted statements, including saying the products were "TGA approved" or attaching a register record, fell within that description.

Mr Harding's personal exposure was dealt with under s 42YC. The Court said that because he aided, abetted, counselled or procured the contraventions, the Act applied as if he had contravened the civil penalty provisions himself. Penalties were sought and ordered under s 42Y.

The reasons also set out the penalty framework. Under s 42Y(3), the Court must have regard to all relevant matters, including the nature and extent of the contravention, any loss or damage suffered, the circumstances in which the contravention took place, and whether the person had previously been found to have engaged in similar conduct. The Court also recorded the maximum penalty figures identified by reference to penalty units at the relevant time.

Because the respondents admitted the conduct, the Court was not deciding a conventional factual contest about whether the events occurred. The hearing proceeded on agreed facts and issues. That changed the Court's task. It still had to be independently satisfied that the agreed facts established contraventions of the Therapeutic Goods Act and that the proposed declarations were framed properly.

The Court also had to decide whether to grant leave under s 500(2) of the Corporations Act to continue the proceeding against Key Promotional after it went into liquidation. The liquidator neither consented nor opposed the grant of leave, but the Court still had to consider whether leave should be given and on what terms.

Another issue was the form of the declarations. The Court emphasised that even where declarations are sought by consent, close attention must be given to whether they disclose the basis on which the contravention occurred and provide sufficient indication of how and why the conduct contravened the Act. That mattered here because the Secretary sought a broader declaration about the false or misleading representations than the Court was prepared to make.

The Court also had to assess the agreed penalties. The reasons explain that where penalties are agreed, the Court's role is to assess the proposed figure against the relevant factors, determine whether it falls within the permissible range, and if no particular figure can be said to be more appropriate than another, accept it as appropriate. The Court referred to the need for some restraint when scrutinising agreed settlement terms where the parties are legally represented.

Longbottom J granted leave for the Secretary to continue the proceeding against Key Promotional under s 500(2) of the Corporations Act. The leave was conditional. The Secretary could continue the case, but could not take any step to enforce against the company any order for payment of money, whether by way of penalty, costs or otherwise, without further leave of the Court.

The Court accepted that there was a real public interest in allowing the proceeding to continue. The reasons refer to the seriousness of the agreed facts, the public interest in vindicating breaches of the Therapeutic Goods Act, and the value of having a public record of contraventions and penalties to deter future contraventions by others. The Court said that this general deterrent function was not defeated by the fact that the company was in liquidation and unable to pay penalties.

The Court made declarations that Key Promotional contravened s 41MIB(1)(a)(i) by importing 255,000 medical devices into Australia between 12 January 2022 and 25 February 2022, and contravened s 41MIB(1)(a)(iii) by supplying 240,720 medical devices in Australia between about 12 January 2022 and about 28 March 2022. It also declared that Key Promotional contravened s 41MLA(1) and s 41MLA(2)(a) by making 2,303 false or misleading representations between 29 December 2021 and 3 March 2022 that the devices were of a kind included in the ARTG.

The Court also made declarations against Mr Harding. It declared that he aided, abetted, counselled or procured the company's import and supply contraventions and was therefore involved in them for the purposes of s 42YC. It further declared that between 4 January 2022 and 3 March 2022 he aided, abetted, counselled or procured 1,183 of the false or misleading representations and was therefore involved in those contraventions as well.

There was one point on which the Court did not accept the broader form of declaration sought by the Secretary. The Court was prepared to declare that the email representations were false or misleading because they represented that the RATs were of a kind included in the Register. But it was not prepared to make a further declaration that they were otherwise false and misleading representations to which s 41MLA applied, because that broader proposition lacked sufficient specificity.

On penalty, the Court ordered by consent that Key Promotional pay $1,750,000 and that Mr Harding pay $250,000. Of Mr Harding's penalty, $70,000 was suspended on condition that he not commit any further civil penalty contravention under, or offence against, any provision of the Therapeutic Goods Act for 10 years. If there is no such contravention or offence, enforcement of the suspended amount is permanently stayed. Costs were also ordered against both respondents.

The case is useful because it shows the main trigger points in a regulated product supply chain. The first trigger is classification. Here, the RATs were medical devices because they were intended to diagnose disease in humans. Once a product falls into that category, the Therapeutic Goods Act can apply before the product is marketed or sold.

The second trigger is importation. The Court accepted that the products were imported when they were brought into Australia. That means risk can arise as soon as stock lands, not only when a sale is completed. The third trigger is supply. The Court accepted that supply occurred when the RATs were delivered to customers. The fourth trigger is representation. Statements to customers, including by email, can create separate contraventions if they falsely suggest the product is included in the ARTG or otherwise use approval language inaccurately.

The reasons also show that the legal position must be checked in relation to the relevant person. The declarations were framed around the fact that the devices were not of a kind included in the Register in relation to Key Promotional. Businesses should be careful not to assume that a product's existence on a register, or a supplier's certificate, automatically authorises their own importation, supply or marketing.

Another practical point is that involvement liability is real. Mr Harding's liability turned on his knowledge of the essential matters constituting the contraventions and his role in aiding, abetting, counselling or procuring them. That means employees and managers cannot assume that only the company is at risk if they know the compliance gap and help the conduct continue.

Businesses should read this case as a practical warning about systems, not just labels. The admitted conduct was not limited to one bad statement. It involved a chain of decisions: obtaining stock, bringing it into Australia, delivering it to customers and sending approval-style messages to the market. If your business handles regulated products, those functions need to be connected by one verified compliance position.

The case also shows that urgency is not a defence to weak process. The Court noted the public health context and the timing shortly after self-administered COVID-19 rapid antigen tests had been approved in Australia. In periods of high demand, businesses can be tempted to move quickly and tidy up the legal position later. This decision shows the risk in doing that.

It is also important to read the case as one about precision. The Court itself insisted on precision in the declarations and refused to make a broader declaration that lacked specificity. Businesses should apply the same discipline internally. If a product is included in the ARTG, know exactly what that means, who it applies to, and what you can accurately say about it. If you cannot state the position precisely, do not market it loosely.

Finally, the case is a reminder that regulators may still pursue declarations and penalties even where a company has gone into liquidation. The Court accepted that there remained a public interest in a public record of contraventions and penalties for deterrence purposes.

The judgment was delivered on 30 April 2026 by Longbottom J in the Federal Court of Australia. The hearing took place on 1 September 2025. The reasons record that the last submissions were dated 15 September 2025.

The available reasons clearly record the orders, the agreed facts, the declarations, the leave to proceed against the company in liquidation, and part of the penalty analysis. The text available for this page ends during the discussion of penalty assessment, so this page focuses on the parts of the decision that are fully visible and reliable.