Date Published: 30 April 2009
Counterfeit medical products
The World Health Organization (WHO) describes counterfeit medicines as "deliberately and fraudulently mislabelled with respect to identity and/or source". Counterfeiting can apply to both branded and generic products. Counterfeits may include products with the wrong ingredients (some of which may be toxic), without active ingredients, with incorrect amounts of active ingredients or with fake packaging.
The WHO estimates that up to 1% of medicines available in the developed world are likely to be counterfeit. This figure rises to 10% globally, although in some developing countries it estimates one third of medicines are counterfeit. Countries with no regulatory system, or those where the regulatory system is still developing, are relatively easy targets for counterfeiters. However, even countries with a fully developed regulatory system cannot afford to be complacent.
Counterfeit medicines or medical devices in the market are a serious threat to public health.
* Consumers risk an unexpected or potentially serious adverse reaction or
perhaps greater harm from leaving a serious medical condition untreated.
* Manufacturers, pharmaceutical companies and healthcare professionals risk the loss of consumer confidence in the event of a counterfeit medicine or medical device getting into the legitimate supply chain.
Australia has a strong and effective regulatory framework for medicines and medical devices, which includes specific legislation that makes the import, export, manufacture or supply of counterfeit medicines and medical devices a crime. The legislation, contained in the Therapeutic Goods Act 1989, carries lengthy terms of imprisonment and heavy fines, or both, upon conviction.
Products are considered counterfeit if the labelling, presentation, advertising, formulation or manufacture of the goods is false.
The TGA closely monitors the supply chain in Australia to prevent counterfeit medicines or medical devices from entering the market. Appropriate safeguards and penalties are also in place to discourage this activity and, when it is detected, the TGA will initiate action aimed at bringing the matter before the court.
Australia’s geographical location and relatively small population means that, to date, we have not been a significant target for counterfeiters. Even so, attempts are made from time to time to import large commercial quantities of counterfeit products. Often, though not always, these products will have been manufactured by an unknown, unlicenced manufacturer and will contain unidentified ingredients including ingredients available in Australia as 'prescription only'.
However, most of the counterfeit products that enter the country are imported in small quantities for personal use by individuals making a purchase via the Internet or by travellers who made the purchase while travelling overseas.
Australian consumers need to be aware of the potential risks associated with purchasing medicines or medical devices from an unknown source including via an unknown Internet site. While the marketing of these products is well targeted and advertised prices may appear cheaper than the price of the same or a similar product purchased from a known source in Australia, it is not unusual for these products to contain too much or too little active ingredient, some will contain the wrong active ingredient and some will contain no active ingredients at all. These products have not been assessed by the TGA for quality or safety and the standards of manufacture are unknown. As a result, the consumer may not receive what they expected and may, in fact, end up importing a dangerous counterfeit medicine or medical device.
Over recent months there has been an increase in the personal importation of lifestyle products claiming to contain only herbal ingredients. Laboratory analysis in Australia has revealed some of these products contain prescription- only ingredients which are not declared on the product labels. These medicines would be regarded as counterfeit under Australian law and are considered to be a public health risk.