The Cost of Drug Development

Abstract

The World Health Organisation (WHO) in 2010 described counterfeit medicines as those which are "Deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging."1 The WHO also now uses the term 'spurious/falsely labelled/falsified/counterfeit (SFFC) medicines'. In addition, there is the related phenomenon of substandard medicines, classified by the WHO as: "Genuine medicines produced by manufacturers authorised by the National Medicines Regulatory Authority (NMRA), which do not meet quality specifications set for them by national medicines."Most of these counterfeit/imitation medicines are manufactured in Asia (predominantly India and China) and Latin America, where patents carry little weight, enforcement agencies are lax and there is a cheap, abundant workforce.