Posted: 3 March 2026
Stephens Lawyers & Consultants has released updated guidance outlining the personal liability risks faced by directors and officers involved in the importation, marketing, advertising and supply of therapeutic goods in Australia.
The update has reinforced that directors and officers are legally responsible for compliance with the Therapeutic Goods Act 1989 (Cth), the Therapeutic Goods Advertising Code and other relevant laws. It has stressed that ignorance of the law is no excuse.
Non-compliance can result in infringement notices and Federal Court proceedings being issued against both the company and its directors and officers. Recent pecuniary penalties imposed on companies for contraventions of the Act have ranged between $2 million and $22 million. Directors and officers have faced personal penalties ranging from $8,000 to $1 million.
The guidance has outlined the factors considered by courts when determining individual liability, including whether a director has “aided, abetted, counselled or procured” a company’s contraventions, or failed to take all reasonable steps to prevent breaches in circumstances where they knew contraventions would occur and were in a position to influence company conduct.
Recent Federal Court decisions involving Oxymed Australia Pty Ltd and Vapor Kings Pty Ltd have demonstrated that directors involved in day-to-day management, advertising campaigns and product supply activities have been held personally liable. In these matters, substantial penalties were imposed on both the companies and their directors following continued non-compliance despite warnings from the Therapeutic Goods Administration (TGA).
The guidance has also highlighted recent criminal prosecutions. In March 2023, Christopher Ramsey was sentenced to two years imprisonment and fined $300,000 for offences relating to the manufacture, supply and advertising of illegal SARMs and nootropic products. In June 2024, Ryan Gregory McTeigue was sentenced to two years imprisonment for unlawful manufacture, supply, advertising and export of therapeutic goods.
Stephens Lawyers & Consultants has emphasised the importance of directors understanding the regulatory framework, implementing proper compliance systems, reviewing advertising materials prior to publication, seeking expert regulatory advice, and ensuring regular education and training for directors, employees and contractors. The update has also noted that Directors’ and Officers’ insurance policies generally exclude cover for civil penalties and criminal fines.
For companies operating in the health technologies sector, the guidance has underscored that active oversight and strong compliance governance are essential to mitigating both corporate and personal regulatory risk.
