The General Regulations currently defines a counterfeit medicine as a medicine in respect of which a false representation has been made about its contents, identity or source by any means including its labelling and packaging.
The proposed definition for falsified medicine describes it as a medicine for which the identity, composition, or source is deliberately or fraudulently misrepresented.
These definitions contain many similarities — the identity, content (composition) or sources of the medicines referred to are misrepresented. In practice these medicines might be labelled as containing a certain active ingredient which it does not contain. This may result in risk to public health if patients receive ineffective treatments.
In the Government Gazette of 1 August 2025, the Minister of Health called for comments regarding proposed amendments of the General Regulations published under the Medicines Act. The proposed amendments include the deletion of the current definition of counterfeit medicine, and the introduction of a definition for falsified medicines. The aim of this short opinion is to evaluate the above change and the rationale behind it.
From the definitions above, it seems that counterfeit and falsified medicines are similar and interchangeable concepts. However, the European Medicines Agency defines counterfeit medicine as medicine made by someone other than the genuine manufacturer, by copying or imitating an original product without authority or rights. Counterfeit medicines infringe trademark law.
Furthermore, the Counterfeit Goods Act protects owners of trademarks, copyright and certain marks under the Merchandise Marks Act, 1941, against the unlawful application of these marks and copyright to goods and against the release of these goods into the channels of commerce.
In short, counterfeit medicines infringe intellectual property rights and are not compliant with the Counterfeit Goods Act. Falsified medicines do not comply with safety, quality and/or efficacy standards required by SAHPRA and will not comply with the Medicines Act. Thus, it is possible to distinguish counterfeit medicines from falsified medicines.
Based on this context, counterfeit medicines fall within the ambit of the Counterfeit Goods Act, and falsified medicines under the Medicines Act.
It is therefore concluded that the rationale for replacing the definition of counterfeit medicines with falsified medicines was necessary to align with the Medicines Act and the mandate of SAHPRA.
