What are counterfeit medicines and devices?

Counterfeit medicines or medical devices are often packaged or marketed to mimic a genuine item. Products are considered counterfeit if the labelling, presentation, advertising, formulation or source of the goods is false. Counterfeiting can apply to both branded (originator) and generic products.

The TGA, with cooperation from State and Territory Governments, closely monitors the supply chain in Australia to prevent counterfeit medicines or medical devices from entering the market.

Risks associated with counterfeit medicines

Although counterfeit medicines may look like genuine medicines, they can potentially contain:

  • the wrong active ingredient
  • no active ingredient
  • too much or too little active ingredient
  • toxic or dangerous substances

Consumers of counterfeit medicines risk unexpected or potentially serious adverse reactions. Consumers can also suffer harm from leaving a serious medical condition untreated or inappropriately treated. Furthermore, counterfeit medicines compete unfairly with legitimate products, and have the potential to weaken public confidence in the health system.

What products are counterfeited?

All therapeutic goods are potential targets for counterfeiters.

Examples of counterfeit medical products can range from widely used medicines such as paracetamol, through to limited use medicines such as cancer and heart medicine. Medical devices, such as specialist contact lenses, condoms, blood glucose test strips and surgical mesh are also subject to counterfeiting.

Counterfeit products detected in Australia are generally lifestyle medicines – such as weight loss, hair loss and erectile dysfunction medicines.

Most of the counterfeit products that enter the country are imported mistakenly in small quantities for personal use by individuals making a purchase via the Internet, or by travellers who made the purchase while travelling overseas.

To avoid purchasing counterfeit products, consumers should exercise caution when buying medicines on the Internet.

The role of the TGA

Counterfeit medicines or medical devices are a serious threat to public health. Importation, manufacture and supply of counterfeit therapeutic goods are subject to specific criminal and civil penalty provisions in the Therapeutic Goods Act 1989. Producing counterfeit therapeutic goods is also a breach of intellectual property.

If counterfeit medical products are detected, the TGA’s Regulatory Compliance Unit (RCU) treats these matters seriously. The RCU may investigate with a view to initiating legal action against the importer, supplier or manufacturer of the products in either criminal or civil law courts.

Upon conviction, offenders can face lengthy terms of imprisonment (up to 7 years) and/or heavy fines. In particular, very heavy fines apply to wrongdoers in breach of the civil penalty provisions in the Therapeutic Goods Act 1989.

Report suspected counterfeit medicine

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA.

Article published on the Australian Government – Therapeutic Goods Administration website
Published: 7 February 2011 (updated 28 October 2014)
Link: https://www.tga.gov.au/node/3989