The suggestions in this article for stronger regulation of substandard “counterfeit” antimicrobial drugs through intellectual property provisions in trade agreements is wrong and dangerous. It is based on the erroneous assumption that IP protection relates to higher quality standards of medicines and that IP enforcement can effectively prevent quality-compromised medicines from reaching the market. This article wrongly conflates issues of IP protection with issues of quality, safety and efficacy of medicines. Such conflation has inspired regulations and actions in the EU that has led to wrongful seizures of generic medicines in transit through European ports, which have been challenged by developing countries in the WTO. Member States of the WHO have agreed to keep away any consideration of IP issues in addressing quality, safety and efficacy of medicines and not use the term “counterfeit” with regard to quality compromised medicines, as the term refers to IP rights.
Competing interests: No competing interests